(c) 2024 PillSync.com

Theraflu (theraflu severe cold relief nighttime soft chews (acetaminophen 325 mg diphenhydramine 12.5 mg) tablet, chewable) Dailymed

  1. Human OTC
    • Drug Classes
  3. Haleon US Holdings LLC

Generic: acetaminophen, diphenhydramine hcl

Theraflu tablet, chewable - (theraflu severe cold relief nighttime soft chews (acetaminophen 325 mg diphenhydramine 12.5 mg) tablet, chewable) image

IMPRINT: N     SHAPE: round
    COLOR: red

  1. FDA Adverse Reactions

Go PRO for all pill images

Active Ingredients (in Each Chewable Tablet)


Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Purposes


Pain reliever/Fever reducer

Antihistamine/Cough suppressant

Uses

  • â–ªtemporarily relieves these symptoms due to a cold:
    • â–ªminor aches and pains
    • â–ªsore throat pain
    • â–ªheadache
    • â–ªrunny nose
    • â–ªsneezing
    • â–ªitchy nose or throat
    • â–ªitchy, watery eyes due to hay fever
    • â–ªcough due to minor throat and bronchial irritation
  • â–ªtemporarily reduces fever

Warnings


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • â–ªmore than 4,000 mg of acetaminophen in 24 hours
  • â–ªwith other drugs containing acetaminophen
  • â–ª3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • â–ªskin reddening
  • â–ªbulers
  • â–ªrash

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

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

Ask a doctor before use if you have

  • â–ªliver disease
  • â–ªglaucoma
  • â–ªtrouble urinating due to an enlarged prostate gland
  • â–ªa breathing problem such as emphysema or chronic bronchitis
  • â–ªcough that occurs with too much phlegm (mucus)
  • â–ªcough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

  • â–ªtaking sedatives or tranquilizers
  • â–ªtaking the blood thinning drug warfarin

When using this product

  • â–ªavoid alcoholic drinks
  • â–ªmarked drowsiness may occur
  • â–ªalcohol, sedatives and tranquilizers may increase drowsiness
  • â–ªbe careful when driving a motor vehicle or operating machinery
  • â–ªexcitability may occur, especially in children

Stop use and ask a doctor if

  • â–ªfever gets worse or lasts more than 3 days
  • â–ªredness or swelling is present
  • â–ªnew symptoms occur
  • â–ªpain or cough gets worse or lasts more than 7 days
  • â–ªcough 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.


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.

Directions

  • â–ªdo not use more than directed
  • â–ªdo not take more than 10 chewable tablets in 24 hours unless directed by a doctor. Take every 4 hours, while symptoms persist.

Age
Dose

adults and children 12 years of age and over
take 2 chewable tablets every 4 hours

children under 12 years of age
do not use

Other Information

  • â–ª each chewable tablet contains: calcium 10 mg, potassium 10 mg, sodium, 7 mg
  • â–ªstore at a controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients


brown iron oxide, calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk

Questions


call 1-855-328-5259

Generic Section


Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION†is broken or missing.

Package/label Principal Display Panel


NEW

THERAFLU

SEVERE COLD RELIEF

NIGHTTIME

Soft CHEWS

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

FAST relief ANYWHERE

fever / cough / headache / body aches / sore throat / runny nose / sneezing / watery eyes

20 CHEWABLE TABLETS

Chew tablets completely before swallowing

Apple Cinnamon Flavor

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

PillSync may earn a commission via links on our site