FDA Label for Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Active ingredients (in each caplet)

Acetaminophen 500 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 15 mg

Otc - Purpose

Purposes

Pain reliever/Fever reducer

Cough suppressant

Purposes

Pain reliever/Fever reducer

Antihistamine

Cough suppressant

Uses

• temporarily relieves these symptoms due to a common cold or flu:
  • headache
  • minor aches and pains
  • cough due to minor throat and bronchial irritation
  • minor sore throat pain
  • temporarily reduces fever
  • temporarily relieves these symptoms due to a common cold or flu:
  • 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.

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.

Otc - 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.
• 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.

Otc - Ask Doctor

• 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
• 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

Otc - Ask Doctor/Pharmacist

• taking the blood thinning drug warfarin
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

Otc - When Using

When using this product do not use more than directed.

• 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

Otc - Stop Use

• pain 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 a rash or headache that lasts

These could be signs of a serious condition.

• pain 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 a rash or headache that lasts

These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a doctor before use.

If pregnant or breast-feeding, ask a doctor before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Keep out of reach of children.

Overdosage

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed
• adults and children 12 years 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

  Age	Dose
  adults and children 12 years of age and over	2 caplets every 6 hours
  children under 12 years of age	do not use

• do not use more than directed
• adults and children 12 years 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

Age	Dose
adults and children 12 years of age and over	2 caplets every 6 hours
children under 12 years of age	do not use

Other Information

Store in a dry place at 15° - 30°C (59° -86°F).

Store in a dry place at 15° – 30°C (59° – 86°F).

Inactive Ingredient

corn starch, crospovidone, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, medium chain triglycerides,
microcrystalline cellulose, mineral oil, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide.

corn starch, crospovidone, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

Otc - Questions

1-800-231-4670

1-800-231-4670

Other

† These products are not manufactured or distributed by Haleon, distributor of Theraflu.

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2024 CVS/pharmacy
CVS.com® 1-800-SHOP CVS

*Maximum Strength per 6 hour dose.

TAMPER EVIDENT FEATURE: FLU RELIEF MAX STRENGTH CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN.

READ ALL WARNINGS 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.

Package Label.Principal Display Panel

CVS Health

Compare to the active ingredients in Theraflu Flu Relief Maximum Strength Daytime & Nighttime caplets†

Multi-Symptom

DAYTIME

MAXIMUM STRENGTH*

Flu Relief

ACETAMINOPHEN

Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr

Cough suppressant

Relieves: Fever, Body aches, Headache, Sore throat pain, Cough

20 CAPLETS

NIGHTTIME

MAXIMUM STRENGTH*

Flu Relief

ACETAMINOPHEN

Pain reliever; Fever reducer

CHLORPHENIRAMINE MALEATE

Antihistamine

DEXTROMETHORPHAN HBr

Cough suppressant

Additional relief of: Runny nose

20 CAPLETS

40 TOTAL CAPLETS