TUSSIN CF ADULT MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Tussin CF by

Drug Labeling and Warnings

Tussin CF by is a Otc medication manufactured, distributed, or labeled by EQUATE (Wal-Mart Stores, Inc.), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 10 mL)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
• temporarily relieves these symptoms occurring with a cold:
  • cough due to minor throat and bronchial irritation
  • nasal congestion

Warnings

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.

Ask a doctor before use if you have

• heart disease
• diabetes
• high blood pressure
• thyroid disease
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
• cough that occurs with too much phlegm (mucus)
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking any other oral nasal decongestant or stimulant.

When using this product,

do not use more than directed.

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• shake well before using
• do not take more than 6 doses in any 24-hour period
• 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
• adults and children 12 years and over: 10 mL every 4 hours
• children under 12 years: do not use

Other information

• each 10 mL contains: sodium 6 mg
• store at 20º-25°C (68º-77°F). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, FD&C red #40, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Questions or comments?

Call 1-888-287-1915

Principal Display Panel

Compare to Robitussin® maximum Strength Multi-Symptom Cold CF Active Ingredients*

TUSSIN CF

Adult Maximum Strength

Multi-Symptom Cold

Cough- Dextromethorphan HBr

Chest Congestion & Mucus- Guaifenesin

Stuffy Nose- Phenylephrine HCl

• For ages 12 and over
• Alcohol free
• Non-Drowsy

FL OZ (mL)

Distributed by: CVS Pharmacy, Inc.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNIGNS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Maximum Strength

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON THE BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

Equate Tussin CF

INGREDIENTS AND APPEARANCE

TUSSIN CF  ADULT MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-412
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-412-08	1 in 1 BOX	02/28/2015	12/30/2021
1		237 mL in 1 BOTTLE, PLASTIC; 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	02/28/2015	12/30/2021

Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)

Registrant - P & L Development, LLC (079765031)