THERAFLU FLU RELIEF MAXIMUM STRENGTH DAYTIME NIGHTTIME COMBO PACK- acetaminophen, dextromethorphan hbr and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Drug Facts
Uses
- •
- temporarily relieves these symptoms due to a common cold:
- •
- headache
- •
- minor aches and pains
- •
- cough due to minor throat and bronchial irritation
- •
- minor sore throat pain
- •
- temporarily reduces fever
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.
- •
- 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
- •
- 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
Directions
- •
- do not use more than directed
- •
- Adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist
- •
- do not take more than 6 caplets in 24 hours unless directed by a doctor
- •
- children under 12 years of age: do not use
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Inactive ingredients
crospovidone, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl
alcohol, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Active ingredients (in each caplet)
Acetaminophen 500 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 15 mg
Uses
- •
- temporarily relieves these symptoms due to a common cold:
- •
- Headache
- •
- minor aches and pains
- •
- cough due to minor throat and bronchial irritation
- •
- minor sore throat pain
- •
- runny nose
- •
- temporarily reduces fever
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.
- •
- 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 a MAO, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- •
- liver disease
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- glaucoma
- •
- trouble urinating due to an enlarged prostate gland
- •
- 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 the blood thinning drug warfarin
- •
- taking sedatives or tranquilizers
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
Directions
- •
- do not use more than directed
- •
- Adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist
- •
- do not take more than 6 caplets in 24 hours unless directed by a doctor
- •
- children under 12 years of age: do not use
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Inactive ingredients
crospovidone, FD&C blue no. 2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, sodium starch
glycolate, stearic acid, talc, titanium dioxide
Other Safety Information
DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.
DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
PARENTS: Learn about teen medicine abuse
www.StopMedicineAbuse.org
*Maximum Strength per 6 hour dose.
TAMPER-EVIDENT FEATURE: THERAFLU FLU RELIEF MAX STRENGTH CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN.
READ ALLWARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 6 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.
DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.
DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
Trademarks are owned by or licensed to the GSK group of companies.
©2022 GSK group of companies or its licensor.
B-0630-770771-10 REV A
Principal Display Panel
NDC 0067-8161-01
THERAFLU
FLU RELIEF
MAX STRENGTH*
MULTI-SYMPTOM FLU RELIEF
Powerful fever fighting formula that relieves:
/ Body ache / Headache
/ Sore throat pain / cough
/ Runny nose (Nighttime only)
DAYTIME
Acetaminophen
Pain Reliever / Fever Reducer
Dextromethorphan HBr
Cough Suppressant
NIGHTTIME
Acetaminophen
Pain Reliever / Fever Reducer
Chlorpheniramine Maleate
Antihistamine
Dextromethorphan HBr
Cough Suppressant
20 DAYTIME CAPLETS
20 NIGHTTIME CAPLETS
40 TOTAL CAPLETS
| THERAFLU FLU RELIEF MAXIMUM STRENGTH
DAYTIME NIGHTTIME COMBO PACK
acetaminophen, dextromethorphan hbr and acetaminophen, chlorpheniramine maleate, dextromethorphan hbr kit |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |