Topcare Nite Time Severe Cold and Flu
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
- Topco Associates LLC
- 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 · 2023-11-03
Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
- Nasal congestion
- Sinus congestion & pressure
- Cough due to minor throat & bronchial irritation
- Cough to help you sleep
- Minor aches & pains
- 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 common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- cough to help you sleep
- minor aches & pains
- headache
- fever
- sore throat
- runny nose & sneezing
- reduces swelling of nasal passages
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
From the official label · 2023-11-03 · DailyMed
How to take it
These directions are for this exact strength and form. Another one is different.
- take only as directed
- do not exceed 8 softgels per 24 hrs
- adults & children 12 yrs & over 2 softgels with water every 4 hours
- children 4 to under 12 yrs
- ask a doctor
- children under 4 yrs
- do not use
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Liver warning:
- This product contains acetaminophen. Severe liver damage may occur
- if you take
- more than 8 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 Allergy alert:
- Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash If a skin reaction occurs,
- stop use and seek medical help right away. 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
- 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.
- Ask a doctor before use
- if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- a sodium-restricted diet
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- Ask a doctor or pharmacist before use
- if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
- Stop use and
- ask a doctor if
- you get nervous, dizzy or sleepless
- pain, nasal congestion, or cough 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. If pregnant or breast-feeding , ask a health professional before use.
- Keep out of reach of children. Overdose warning:
Quoted from the official label, section “Warnings”.
Keep away from children
- Overdose warning:
- In case of overdose, get medical help or contact a Poison Control Center right away.
Quoted from the official label, section “OTC — Keep Out of Reach of Children”.
How to store it
- store at 20-25°C (68-77°F)
- protect from light, heat and moisture
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.
edible printing ink, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution
Quoted from the official label, section “Inactive Ingredients”.
Questions about this product
Call 1-888-423-0139
Quoted from the official label, section “OTC — Questions”.
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 no. 1
Some people react to dyes such as tartrazine (Yellow 5) or carmine. - Sugar alcohols
sorbitol sorbitan solution
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
- Topcare Nite Time Severe Cold and FluThis oneWithout prescriptionTopco Associates LLCColour 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
- Night Cold Flu Cough and AllergyWithout 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
- 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 | Topco Associates LLC |
|---|---|
| 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 | 2 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| NDC | 76162-812 |
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.