Night Cold Flu Cough and Allergy
325 mg + 10 mg + 6.25 mg + 5 mg · Capsule, Liquid Filled
- Available without prescription
- Antihistamine
- Active substance
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
- Made by
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2024-11-25
Pain reliever/ fever reducer Cough suppressant Antihistamine Nasal decongestant
- Minor aches and pains headache nasal and sinus congestion cough sore throat runny nose sneezing temporarily reduces fever
Adults and children 12 years of age and over:: take 2 softgels with water every 4 hours.
Do not exceed 10 softgels in 24 hours or as directed by a doctor.
Full directions ↓With any other drug containing acetaminophen (prescription or nonprescription).
All warnings ↓- Sold without a prescription
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
temporarily relieves these symptoms due to a cold or flu:
- minor aches and pains headache nasal and sinus congestion cough sore throat runny nose sneezing temporarily reduces fever
From the official label · 2024-11-25 · DailyMed
Do not take it if
- with any other drug containing acetaminophen (prescription or nonprescription).
- If you are not sure whether a drug contains acetaminophen,
- ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.
- If you do not know if your prescription drug contains an MAOI,
- ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients in
- children under 12 years of age
Quoted from the official label, section “OTC — Do Not Use”.
How to take it
These directions are for this exact strength and form. Another one is different.
- do not take more than the recommended dose
- adults and children 12 years of age and over:
- take 2 softgels with water every 4 hours.
- Do not exceed 10 softgels in 24 hours or as directed by a doctor.
- children under 12 years of age:
- do not use
Quoted from the official label, section “Dosage & Administration”.
Ask a doctor first if
liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Quoted from the official label, section “OTC — Ask Doctor”.
Ask a pharmacist first if
you are taking the blood thinning drug warfarin taking sedatives or tranquilizers
Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.
Stop and get help if
- pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts.
- These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs
Quoted from the official label, section “OTC — Stop Use”.
Other warnings
- Liver warning This product contains acetaminophen.
- Severe liver damage may occur
- if you take more than 10 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
- Do not use to sedate children.
- Do not use with any other drug containing acetaminophen (prescription or nonprescription).
- Ask a doctor before use
- if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- Ask a doctor or pharmacist before use
- if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers
- When using this product
- do not exceed recommended dosage may cause marked drowsiness
- avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
- Stop use and
- ask a doctor
- if pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts.
- These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children.
- do not exceed recommended dosage may cause marked drowsiness
- avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Keep away from children
- In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for
- adults as well as for children even
- if you do not notice any signs or symptoms.
Quoted from the official label, section “OTC — Keep Out of Reach of Children”.
How to store it
store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
Quoted from the official label, section “Storage and Handling”.
What kind of medicine it is
Pain reliever/ fever reducer Cough suppressant Antihistamine Nasal decongestant
Quoted from the official label, section “OTC — Purpose”.
Other ingredients
Relevant if you react to a dye, a preservative, lactose or gluten.
- FD&C blue #1, D&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink Manufactured by:
- Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China
Quoted from the official label, section “Inactive Ingredients”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
- Colour dyes
FD&C blue #1; D&C yellow #10
Some people react to dyes such as tartrazine (Yellow 5) or carmine. - Sugar alcohols
sorbitol special
Sorbitol and similar can upset the stomach and matter with fructose intolerance. - Gelatin
gelatin
Animal-derived: matters for vegetarian, vegan, halal and kosher diets.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (14)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 14 of 14
- Night Cold Flu Cough and AllergyThis oneWithout prescriptionHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.Colour dyesSugar alcoholsGelatin
- Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and CoughWithout prescriptionBayer HealthCare LLC.Colour dyesSugar alcoholsGelatinTitanium dioxide
- Quality Choice Maximum Strength Nighttime Cold and FluWithout prescriptionChain Drug Marketing Association, Inc.Colour dyesSugar alcoholsGelatinTitanium dioxide
- Quality Choice Nighttime Severe Cold and FluWithout prescriptionChain Drug Marketing Association, Inc.Colour dyesSugar alcoholsGelatin
- Asp Nighttime MaxWithout prescriptionHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.Colour dyesSugar alcoholsGelatin
- Hyvee Nighttime Severe Cold and Flu SoftgelWithout prescriptionHyVee IncColour dyesSugar alcoholsAlcohol (ethanol)GelatinTitanium dioxide
- Maximum Strength Nighttime Severe Cold and FluWithout prescriptionProdose, Inc.Colour dyesSugar alcoholsGelatinTitanium dioxide
- Night Time Severe Cold and Flu ReliefWithout prescriptionPuraCap Pharmaceutical LLCColour dyesSugar alcoholsGelatin
- Severe Sinus Congestion Allergy and Cough FormulaWithout prescriptionPuraCap Pharmaceutical LLCColour dyesSugar alcoholsGelatin
- Night Time Cold and FluWithout prescriptionRetail Business Services, LLCColour dyesSugar alcoholsGelatin
- Right Remedies Nighttime Severe Cold and Flu SoftgelWithout prescriptionStrive Pharmaceuticals Inc.Colour dyesSugar alcoholsGelatinTitanium dioxide
- Nitetime Severe Cold and Flu Relief SoftgelsWithout prescriptionTopco Associates LLCColour dyesSugar alcoholsGelatinTitanium dioxide
- Topcare Nite Time Severe Cold and FluWithout prescriptionTopco Associates LLCColour dyesSugar alcoholsGelatin
- Equate Maximum Strength Nighttime Severe Cold and Flu SoftgelsWithout prescriptionWALMART INC.Colour dyesSugar alcoholsGelatinTitanium dioxide
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. |
|---|---|
| Active substance | Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride |
| Used in | Breathing, airways, allergies and cough |
| Strength | 325 mg + 10 mg + 6.25 mg + 5 mg |
| Form | Capsule, Liquid Filled |
| Route | Oral |
| Packs | 1 BAG in 1 BOX / 4000 CAPSULE, LIQUID FILLED in 1 BAG |
| NDC | 53345-020 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.