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Family Dollar
Aaron Industries, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCI 5 mg

Purposes

Acetaminophen..................................Pain reliever/fever reducer
Dextromethorphan HBr.....................Cough suppressant
Phenylephrine HCI............................Nasal decongestant

Day Time Uses

temporarily relieves these common cold/flu symptoms:
• minor aches and pains • headache • sore throat • fever
• nasal congestion • cough due to minor throat and bronchial irritation

Warnings

Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 6 doses (12 tablespoonfuls or 180 mL) in 24 hours for adults
• more than 5 doses (5 tablespoonfuls or 75 mL) in 24 hours for
children 6-12 years old
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday while using this product
Sore throat warning: If sore throat is severe, persists for more than 2 days,
is accompanied or followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.

Do Not Use

• if you are on a sodium-restricted diet
• 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 two 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. • with any other drug containing acetaminophen (prescription or
non-prescription). If you are not sure whether a drug contains acetaminophen, ask a
doctor or pharmacist.

Ask a doctor before use if you have

• liver disease • heart disease • thyroid disease • diabetes • high blood pressure
• persistent or chronic cough such as occurs with smoking, asthma or emphysema
• cough accompanied by excessive phlegm (mucus)
• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

When using this product

• avoid alcoholic drinks
• do not use more than directed (see overdose warning)

Stop use and ask a doctor if

• redness or swelling is present • new symptoms occur
• you get nervous, dizzy or sleepless
• pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
• fever gets worse or lasts more than 3 days
• cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use.

Keep this and all drugs out of the reach of children.

Overdose Warning: Taking more than the recommended dose (overdose) could cause
serious health problems, including liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control Center immediately. Quick medical
attention is critical for adults as well as for children even if you do not notice any signs
or symptoms.

Directions




AgeDose







Other Information

• sodium content per tablespoon: 71 mg
• store at controlled room temperature

Inactive Ingredients

citric acid, flavor, glycerin, polyethylene glycol,
propylene glycol, purified water, saccharin sodium, sodium citrate,
sucrose, yellow 6

Principal Display Panel










Day Time

Day Time

Acetaminophen.Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55319-341
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
POLYETHYLENE GLYCOL 300
propylene glycol
water
SACCHARIN SODIUM ANHYDROUS
SODIUM CITRATE
SUCROSE
FD&C YELLOW NO. 6

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55319-341-61 296 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2009-06-30


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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