FDA Label for Family Care Cold And Flu Multi Symptom

Otc - Active Ingredient

Active ingredients (in each 30 mL dose cup)                                              Purpose

Acetaminophen 650 mg...............................................Pain reliever/fever reducer

Dextromethorphan HBr 30 mg................................................Cough suppressant

Doxylamine succinate 12.5 mg.......................................................Antihistamine

Otc - Purpose

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• fever
• running nose and sneezing

Warnings

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks daily while using this product

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

Otc - 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 presction 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.
• to make a child sleep

Otc - Ask Doctor

Ask a doctor before use if you have

• liver disease
• glaucoma
• 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-restricted diet

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thining drug warfarin

Otc - When Using

When using this product

• excitability may occur, especially in chldren
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• pain or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 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.

Otc - Pregnancy Or Breast Feeding

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

Otc - 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. 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
• use dose cup or tablespoon (TBSP)
• do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over	30 mL (2 TBSP) every 6 hrs
children 4 to under 12 yrs	ask a doctor
children under 4 yrs	do not use

Storage And Handling

Other information

• each 30 mL dose cup contains:
• potassium 3 mg
• sodium 7 mg
• store at room temperature

Inactive Ingredient

Inactive ingredients

acesulfame potassium, alcohol, cherry essence, citric acid hydrate, FD&C Blue No. 1, FD&C Red No. 40, high fructose corn syrup, L-menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate hydrate, sodium saccharin

Dosage & Administration

Distributed by:

United Exchange Corp.

Cerritos, CA 90703 U.S.A.

Made in Korea

Package Label.Principal Display Panel

image description - 630