Label: ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR kit
- NDC Code(s): 51316-451-01, 51316-983-01, 51316-984-03
- Packager: CVS Pharmacy, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 31, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Day Time Flu Relief Maximum Strength
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
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.
- 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.
- 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 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
- temporarily relieves these symptoms due to a common cold or flu:
-
Nighttime Flu Relief Maximu Strength
Drug facts
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 or flu:
- headache
- minor aches and pains
- cough due to minor throat and bronchial irritation
- minor sore throat pain
- runny nose
- temporarily reduces fever
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.
- 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.
- 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
- 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 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 -
SPL UNCLASSIFIED SECTION
† 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. -
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
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-984 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-984-03 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 07/10/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 BLISTER PACK 20 in 40 Part 2 2 BLISTER PACK 20 in 40 Part 1 of 2 ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr tablet, film coatedProduct Information Item Code (Source) NDC:51316-451 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TRIACETIN (UNII: XHX3C3X673) MINERAL OIL (UNII: T5L8T28FGP) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color blue Score no score Shape OVAL Size 18mm Flavor Imprint Code C451 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-451-01 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/10/2024 Part 2 of 2 ACETAMINOPHEN, DEXTROMETHORPHAN HBR
acetaminophen, dextromethorphan hbr tablet, film coatedProduct Information Item Code (Source) NDC:51316-983 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T) MINERAL OIL (UNII: T5L8T28FGP) CROSPOVIDONE (UNII: 2S7830E561) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color red Score no score Shape OVAL Size 18mm Flavor Imprint Code C642 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-983-01 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/10/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/10/2024 Labeler - CVS Pharmacy, Inc (062312574)