FAMILY CARE COUGH AND COLD- dextromethorphan hydrobromide, and guaifenesin liquid

Family Care Cough and Cold by

Drug Labeling and Warnings

Family Care Cough and Cold by is a Otc medication manufactured, distributed, or labeled by United Exchange Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each 10 mL)                                                               Purpose

Dextromethorphan HBr, USP 20 mg............................................Cough suppressant

Guaifenesin, USP 200 mg....................................................................Expectorant

PURPOSE

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to drain brnchial tubes.

WARNINGS

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 until 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 DOCTOR

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)
• or a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

STOP USE

Stop use and ask a doctor if

• 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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

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.

INDICATIONS & USAGE

Directions

• 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

• age: dose
• adults and children 12 years and over: 10 mL every 4 hours
• children under 12 years: do not use

STORAGE AND HANDLING

Other information

• each 10 mL contains: sodium 3 mg
• Store at 20° to 25°C (68° to 77°F). Do not refrigerate.

INACTIVE INGREDIENT

Inactive ingredients

citric acid hydrate, FD&C red no. 40, fruit mixing essence, glycerin, high fructose corn syrup, L-menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate hydrate, sucralose

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY CARE COUGH AND COLD 
dextromethorphan hydrobromide, and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-633
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	40 mg  in 10 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
MENTHOL (UNII: L7T10EIP3A)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-633-04	118 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	07/29/2015

Labeler - United Exchange Corp. (840130579)