Label: CVS SEVERE MULTI-SYMPTOM COUGH COLD FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
- NDC Code(s): 51316-630-04, 51316-630-08
- Packager: CVS PHARMACY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 20, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each 20 ml)
- Purposes
-
INDICATIONS & USAGE
Uses
- temporarily relieves these symptoms occurring with a cold or flu:
- cough due to minor throat and bronchial irritation
- nasal congestion
- sinus congestion and pressure
- minor aches and pains
- sore throat
- headache
- temporarily reduces fever
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes 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 6 doses in any 24-hour period, which is the maximum daily amount
- 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.
Do not use
- 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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking any other oral nasal decongestant or stimulant
- taking any other pain reliever/fever reducer
Stop use and ask a doctor if
- you get nervous, dizzy, or sleepless
- pain, cough, or nasal congestion 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 rash or headache that lasts. These could be signs of a serious condition.
-
DOSAGE & ADMINISTRATION
Directions
- do not take more than 6 doses in any 24-hour period
- do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
- measure only with dosing cup provided
- keep dosing cup with product
- ml = milliliter
- this adult product is not intended for use in children under 12 years of age
age dose adults and children 12 years and over
20 ml every 4 hours
children under 12 years
do not use
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL
Compare to the active ingredients in Adult Robitussin Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX*
NDC 51316-630-04
MAXIMUM STRENGTH
Adult
SEVERE
Multi-Symptom
Cough Cold + FluACETAMINOPHEN (Pain Reliever/Fever Reducer)
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
Phenylephrine HCl (Nasal Decongestant)- Cough, Sore Throat
- Body Aches, Fever
- Nasal Congestion
- Chest Congestion
Sugar-Free
No Added Alcohol
Natural Raspberry Flavor
For Ages 12 & Over
8 FL OZ (237 ml)*This product is not manufactured or distributed by GSK Consumer Healthcare, Owner o the registered trademark Adult Robitussin Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX.
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INGREDIENTS AND APPEARANCE
CVS SEVERE MULTI-SYMPTOM COUGH COLD FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-630 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 20 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POTASSIUM CITRATE (UNII: EE90ONI6FF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color red Score Shape Size Flavor RASPBERRY, CHOCOLATE, MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-630-04 1 in 1 CARTON 01/09/2023 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:51316-630-08 1 in 1 CARTON 01/09/2023 2 237 mL in 1 BOTTLE; 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 01/09/2023 Labeler - CVS PHARMACY (062312574)
