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
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hbr (NDC 51316-984). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
Purposes
Pain reliever/Fever reducer
Cough suppressant
Purposes
Pain reliever/Fever reducer
Antihistamine
Cough suppressant
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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
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.
When using this product do not use more than directed.
These could be signs of a serious condition.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a doctor before use.
If pregnant or breast-feeding, ask a doctor before use.
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 (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.
| 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 |
| 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 |
Store in a dry place at 15° - 30°C (59° -86°F).
Store in a dry place at 15° – 30°C (59° – 86°F).
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.
1-800-231-4670
1-800-231-4670
† 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.
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
* Please review the disclaimer below.