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NDC 69842-0947-08 CVS Severe Tussin CF Max 650; 20 mg/20mL; mg/20mL Details

CVS Severe Tussin CF Max 650; 20 mg/20mL; mg/20mL

CVS Severe Tussin CF Max is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by CVS PHARMACY. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 69842-0947-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 69842-0947-08
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan

Product Information

NDC	69842-0947
Product ID	69842-947_758db606-7c6a-49f2-9b49-24f69166af86
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CVS Severe Tussin CF Max
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen, Dextromethorphan HBr
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	650; 20
Active Ingredient Units	mg/20mL; mg/20mL
Substance Name	ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Labeler Name	CVS PHARMACY
Pharmaceutical Class	Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69842-0947-08 (69842094708)

Pricing Information	N/A
NDC Package Code	69842-947-08
Billing NDC	69842094708
Package	1 BOTTLE in 1 CARTON (69842-947-08) / 237 mL in 1 BOTTLE
Marketing Start Date	2019-04-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e32881f5-2bb5-4756-aa86-a09473ab590b Details

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

CVS.com

1-800-SHOP CVS

V-12431

CVS Quality

Money Back Guarantee

CVS Health Max Strength Acetaminophen, Dextromethorphan HBr

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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 BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	04/15/2019

Labeler - CVS PHARMACY (062312574)

Revised: 6/2022

Document Id: 758db606-7c6a-49f2-9b49-24f69166af86

Set id: e32881f5-2bb5-4756-aa86-a09473ab590b

Version: 4

Effective Time: 20220629