TUSSIN CF MULTI-SYMPTOM COLD- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Tussin CF Multi-Symptom Cold by

Drug Labeling and Warnings

Tussin CF Multi-Symptom Cold by is a Otc medication manufactured, distributed, or labeled by DeMoulas Market Basket, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTSActive ingredients(in each 5 mL tsp)

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg
Phenylephrine HCL, USP 5 mg

Purposes

Cough Suppressant
Expectorant
Nasal Decongestant

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

•  help loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

•  temporarily relieves these symptoms occurring with a cold

•  nasal congestion

•  cough due to minor throat and bronchial irritation

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 Ask a doctor or pharmacist before use

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

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

• you get nervous, dizzy or sleepless
• 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.

Directions

• Do not take more than 6 doses in any 24 hour period
• This adult strength product is not intended for use in children under 12 years of age

Age                                                                               Dose
adults and children 12 years and over                               2 teaspoons every 4 hours

 children under 12                                                           do not use

Other information

• Keep carton for full Direction for use.
• store at 20‐25 ° C (68‐77 ° F)
• do not refrigerate
• dosage cup provided
• sodium 3 mg per teaspoonful

Inactive ingredients

anhydrous citric acid, FD and C red no. 40, glycerin, menthol, e,
natural and artificial flavor, propylene glycol purified water, sodium benzoate sorbitol solution, sucralose

Questions?

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Product Label

"MORE FOR YOUR DOLLAR"

MARKET BASKET®

*COMPARE TO THE ACTIVE INGREDIENTS IN ROBITUSSIN® PEAK COLD MULTI-SYMPTOM COLD

Tussin CF Multi-Symptom Cold

Dextromethorphan HBr/ Guaifenesin / Phenylephrine HCL

COUGH SUPPRESSANT
EXPECTORANT/
NASAL DECONGESTANT

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Relieves:

• Cough
• Mucus
• Nasal Congestion

NON-DROWSY

ADULT
for ages 12 and over

8 FL OZ (237 mL)

*This product is not manufactured or distributed by Pfizer, owner of the trademark Robitussin ®

DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.   875 EAST STREET TEWKSBURG, MA 01876   BX-013

INGREDIENTS AND APPEARANCE

TUSSIN CF MULTI-SYMPTOM COLD 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53942-504
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53942-504-26	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/20/2012

Labeler - DeMoulas Market Basket (007869647)

Registrant - DeMoulas Market Basket (007869647)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(53942-504)