FAMILY CARE COLD AND FLU MULTI SYMPTOM- acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid

Family Care Cold and Flu Multi Symptom by

Drug Labeling and Warnings

Family Care Cold and Flu Multi Symptom 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 15 mL dose cup)                                               Purpose

Acetaminophen 325 mg................................................Pain reliever/fever reducer

Dextromethorphan HBr 10 mg..................................................cough suppressant

Phenylephrine HCI 5 mg.........................................................Nasal decongestant

PURPOSE

Uses temporarily relieves common cold/flu symptoms:

• nasal congestion
• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• fever

WARNINGS

Warnings

Liver warning: This product contains acetaminophen. Sever liver damage may occur if

• adult takes more than 4 (30 mL each) doses in 24 hours, which is the maximum daily amount for this product
• child takes more than 4 doses (15 mL each) in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

Sore throat warning: if sore throat is sever, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

DO NOT USE

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• 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 DOCTOR

Ask a doctor before use if you have

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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

WHEN USING

When using this product

• do not use more than directed

STOP USE

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• pain or cough 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.

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. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

INDICATIONS & USAGE

Directions

• take only as directed - see Overdose warning
• use dose cup or tablespoon (TBSP)
• do not exceed 4 doses per 24 hrs

adults & children 12 yrs over: 30 mL (2TBSP) every 4 hours

children 6 to under 12 yrs: 15 mL(1 TBSP) every 4 hours

children 4 to under 6 yrs: ask a doctor

children under 4 yrs: do not use

STORAGE AND HANDLING

Other information

• each 15 mL dose cup contains: sodium 25 mg
• store at room temperature

INACTIVE INGREDIENT

Inactive ingredients

citric acid hydrate, D-sorbitol, FD&C Yellow No. 6, glycerin, L-menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium chloride, sodium citrate hydrate, sodium saccharin, xanthan gum

DOSAGE & ADMINISTRATION

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY CARE COLD AND FLU MULTI SYMPTOM 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-627
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SORBITOL (UNII: 506T60A25R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
MENTHOL (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-627-04	118 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	07/23/2015

Labeler - United Exchange Corp. (840130579)