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 November 2, 2023
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- Official Label (Printer Friendly)
- Active ingredients (in each 20 ml)
- Purposes
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INDICATIONS & USAGE
Uses
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- temporarily relieves these symptoms occurring with a cold or flu:
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- cough due to minor throat and bronchial irritation
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- nasal congestion
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- sinus congestion and pressure
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- minor aches and pains
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- sore throat
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- headache
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- temporarily reduces fever
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- 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
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- more than 6 doses in any 24-hour period, which is the maximum daily amount
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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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- 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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- 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
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
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- 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
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- taking the blood thinning drug warfarin
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- taking any other oral nasal decongestant or stimulant
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- taking any other pain reliever/fever reducer
Stop use and ask a doctor if
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- you get nervous, dizzy, or sleepless
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- pain, cough, or nasal congestion gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
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DOSAGE & ADMINISTRATION
Directions
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- do not take more than 6 doses in any 24-hour period
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- do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
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- measure only with dosing cup provided
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- keep dosing cup with product
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- ml = milliliter
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- 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
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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)
