CVS SEVERE TUSSIN CF MAX- acetaminophen, dextromethorphan hbr solution

CVS Severe Tussin CF Max by

Drug Labeling and Warnings

CVS Severe Tussin CF Max by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 20 mL)

Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Uses

• ▪ temporarily relieves these symptoms occurring with a cold or flu:
• ▪ cough due to minor throat and bronchial irritation
• ▪ minor aches and pains
• ▪ sore throat
• ▪ headache
• ▪ temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• ▪ more than 6 doses in any 24 hours 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
• ▪ cough that occurs with too much phlegm (mucus)
• ▪ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

• ▪ taking the blood thinning drug warfarin
• ▪ Taking any other pain reliever/fever reducer

When using this product do not use more than directed.

Stop use and ask a doctor if

• ▪ 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

Other information

• each 20 mL contains: sodium 13 mg
• store at room temperature Do not refrigerate.

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red #40, glycerin, menthol, flavors, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

Questions or comments?

1-866-467-2748

Principal Display Panel

Compare to active ingredients in Robitussin® Maximum Strength Severe Cough + Sore Throat*

NDC# 69842-947-08

MAXIMUM STRENGTH

Non–Drowsy

Severe Tussin CF Max

ACETAMINOPHEN

Pain reliever / Fever reducer

DEXTROMETHORPHAN HBr

Cough Suppressant

Adult Cough & Sore Throat

Relieves:

• Cough
• Sore throat pain

For Ages 12 Years & older

Dosage cup provided

Actual Product Size on Side Panel

8 FL OZ (237 mL)

*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin Maximum Strength Severe Cough + Sore Throat.

Maximum Strength claim based on maximum levels of active ingredients per dose.

IMPORTANT: Keep this carton for future reference on full labeling.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2019 CVS/pharmacy

CVS.com

1-800-SHOP CVS

V-12431

CVS Quality

Money Back Guarantee

INGREDIENTS AND APPEARANCE

CVS SEVERE TUSSIN CF MAX 
acetaminophen, dextromethorphan hbr solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-947
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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-947-08	1 in 1 CARTON	04/15/2019
1		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 final	part341	04/15/2019

Labeler - CVS PHARMACY (062312574)