Label: THERAFLU RELIEF MAX STRENGTH NIGHTTIME- acetaminophen, chlorpheniramine maleate and dextromethophan hbr powder, for solution
- NDC Code(s): 51316-549-06
- Packager: CVS PHARMACY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 4, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each packet)
- Purposes
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- in a child under 12 years of age
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- if you are allergic to acetaminophen
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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
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- liver disease
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- glaucoma
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- trouble urinating due to an enlarged prostate gland
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- a breathing problem such as emphysema or chronic bronchitis
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
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- taking the blood thinning drug warfarin
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- taking sedatives or tranquilizers
When using this product
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- avoid alcoholic drinks
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- marked drowsiness may occur
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
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- excitability may occur, especially in children
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Directions
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- do not use more than directed
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- take every 6 hours, while symptoms persist. Do not take more than 3 packets in 24 hours unless directed by a doctor.
- Age
- Dose
- adults and children 12 years of age and over
- one packet
- children under 12 years of age
- do not use
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- dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
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- if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
*Compare to the active ingredients in Theraflu Multi-Symptom Flu Relief Max Strength** Nighttime
NDC 51316-549-06
Nighttime
Flu Relief
MAX STRENGTH**
Acetaminophen Pain Reliever/Fever Reducer
Chlorpheniramine Maleate Antihistamine
Dextromethorphan HBr Cough Suppressant
Honey Lemon
Natural & Artificial Flavored
1 SINGLE DOSE
TO OPEN: CUT ALONG DOTTED LINE WITH SCISSORS DO NOT USE IF SEALED PACKET IS TORN OR BROKEN
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Multi-Symptom Flu Relief Max Strength** Nighttime.
**Maximum Strength per 6 hours dose
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court,
East Brunswick, NJ 08816
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INGREDIENTS AND APPEARANCE
THERAFLU RELIEF MAX STRENGTH NIGHTTIME
acetaminophen, chlorpheniramine maleate and dextromethophan hbr powder, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-549 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 1000 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARAMEL (UNII: T9D99G2B1R) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) Product Characteristics Color WHITE ((white to off-white, yellow, beige, and brown color)) Score Shape Size Flavor HONEY (Lemon) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-549-06 1 in 1 PACKET; Type 0: Not a Combination Product 04/17/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/17/2023 Labeler - CVS PHARMACY (062312574)
