Medicine guide

Theraflu Nighttime Severe Cold and Cough

650 mg/237mL + 25 mg/237mL + 10 mg/237mL · Powder, for Solution

Available without prescription
Histamine-1 Receptor Antagonist

Active substance: Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
Used in: Breathing, airways, allergies and cough
Made by: Haleon US Holdings 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 · 2024-01-28

What it is

Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant

Used for

Minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation…

How to take it

Do not take more than 5 packets in 24 hours unless directed by a doctor.

Full directions ↓

Do not take it if

In a child under 12 years of age

All warnings ↓

Good to know

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

12other products contain Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl — compare makers, forms and strengths

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:

minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever

From the official label · 2024-01-28 · DailyMed

Do not take it if

in a child under 12 years of age
if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription).
If you are not sure whether a drug contains acetaminophen,
ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on the skin
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.

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 use more than directed take every 4 hours, while symptoms persist.
Do not take more than 5 packets in 24 hours unless directed by a doctor.
Age Dose
adults and children 12 years of age and over one packet
children under 12 years of age
do not use dissolve contents of one packet into 8 oz. hot water; sip while hot.
Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating.
Do not overheat.

Quoted from the official label, section “Dosage & Administration”.

Ask a doctor first if

Ask doctor before use
if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic 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 sedatives or tranquilizers taking the blood thinning drug warfarin

Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.

Stop and get help if

nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.

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 4,000 mg of acetaminophen in 24 hours 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 in a child under 12 years of age
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 exceed recommended dosage
avoid alcoholic drinks marked drowsiness may occur 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 nervousness, dizziness, or sleeplessness occurs fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or lasts more than 7 days cough comes back or occurs with rash or headache that lasts.
Keep out of reach of children.
do not exceed recommended dosage
avoid alcoholic drinks marked drowsiness may occur 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. Prompt 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

each packet contains :
potassium 10 mg, sodium 23 mg phenylketonurics :
contains phenylalanine 13 mg per packet
store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.

Quoted from the official label, section “Storage and Handling”.

What kind of medicine it is

Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant

Quoted from the official label, section “OTC — Purpose”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

Quoted from the official label, section “Inactive Ingredients”.

Questions about this product

call 1-855-328-5259

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 dyesD&C yellow no. 10; FD&C blue no. 1; FD&C red no. 40Some people react to dyes such as tartrazine (Yellow 5) or carmine.
SugarssucroseRelevant to diabetes and dental health.
Aspartame (phenylalanine)aspartamePeople with phenylketonuria (PKU) must avoid phenylalanine.

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 (2)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 2 of 2

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

Every strength and form (9)

Details

Made by	Haleon US Holdings LLC
Active substance	Acetaminophen, Diphenhydramine Hcl, Phenylephrine Hcl
Used in	Breathing, airways, allergies and cough
Strength	650 mg/237mL + 25 mg/237mL + 10 mg/237mL
Form	Powder, for Solution
Route	Oral
Packs	6 PACKET in 1 CARTON / 237 mL in 1 PACKET
NDC	0067-7918

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).

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

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