Label: MAXIMUM STRENGTH COLD, FLU AND SORE THROAT- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filled
- NDC Code(s): 69842-616-16
- Packager: CVS Pharmacy, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 2, 2023
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- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
- Temporarily relieves these common cold and flu symptoms:
nasal congestion
headache
cough
minor aches and pains
sore throat
sinus congestion and pressure
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
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WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:- more than 12 softgels in 24 hrs, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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
Do not use
- 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.
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ASK DOCTOR
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, 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 fever, rash, or headache that lasts. These could be signs of a serious condition.
- PREGNANCY OR BREAST FEEDING
-
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. - DOSAGE & ADMINISTRATION
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH COLD, FLU AND SORE THROAT
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-616 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GLYCERIN (UNII: PDC6A3C0OX) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color orange Score no score Shape OVAL Size 26mm Flavor Imprint Code 78 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-616-16 1 in 1 CARTON 07/10/2021 1 8 in 1 BLISTER PACK 1 8 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 07/10/2021 Labeler - CVS Pharmacy, Inc. (062312574) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(69842-616)