Theraflu Severe Cold Relief Nighttime Soft Chews ACETAMINOPHEN DIPHENHYDRAMINE HCL HALEON US HOLDINGS LLC FDA Approved Uses temporarily relieves these symptoms due to a cold: minor aches and pains sore throat pain headache 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
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each chewable tablet) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg
Inactive Ingredients
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
Strengths
325 mg 12.5 mg
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To A Cold Minor Aches And Pains Sore Throat Pain Headache 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
Pill Appearance
Shape: round Color: red Imprint: N

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D TC2D6JAD40
Packaging

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 Theraflu SC Night Soft Chews 20 ct

Package Descriptions
  • 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 Theraflu SC Night Soft Chews 20 ct

Overview

Uses temporarily relieves these symptoms due to a cold: minor aches and pains sore throat pain headache 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

Indications & Usage

Uses temporarily relieves these symptoms due to a cold: minor aches and pains sore throat pain headache 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

Dosage & Administration

Directions do not use more than directed do 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

Warnings & Precautions
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 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 Ask a doctor before use if you have liver disease 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 Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product 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 fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain or cough 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. 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.
Purpose

Purposes Pain reliever/Fever reducer Antihistamine/Cough suppressant

Do Not Use

Do not use 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

When Using

When using this product 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 & Ask a Doctor

Stop use and ask a doctor if fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain or cough 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.

Keep Out of Reach of Children

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.

Questions

Questions or comments? call 1-855-328-5259


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