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allergy and cough

Western Family Foods Inc

Western Family Allergy & Cough Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

allergy and cough Uses

  • •temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • •runny nose
  • •sneezing
  • •itching of the nose or throat
  • •itchy, watery eyes
  • •temporarily relieves these symptoms due to a cold:
  • •nasal congestion
  • •sinus congestion and pressure
  • •headache
  • •minor aches and pains
  • •cough
  • •temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 capsules (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

  • •more than 4,000 mg of acetaminophen in 24 hours
  • •with other drugs containing acetaminophen
  • •3 or more alcoholic drinks every day while using this product

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.
  • •if you have ever had an allergic reaction to this product or any of its ingredients
  • •in children under 12 years of age
  • •to make a child sleepy

Ask a doctor before use if you have

  • •liver disease
  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •glaucoma
  • •cough with excessive phlegm (mucus)
  • •a breathing problem such as emphysema or chronic bronchitis
  • •difficulty in urination due to enlargement of the prostate gland
  • •persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

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

When using this product

  • •do not exceed recommended dosage
  • •may cause marked drowsiness
  • •avoid alcoholic drinks
  • •alcohol, sedatives, and tranquilizers may increase drowsiness
  • •be careful when driving a motor vehicle or operating machinery
  • •excitability may occur, especially in children

Stop use and ask a doctor if

  • •pain, cough, or nasal congestion 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.
  • •nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • •do not take more than directed (see overdose warning)
  • •adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
  • •children under 12 years: do not use

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Principal Display Panel

Severe Sinus Congestion

Acetaminophen/Pain reliever-fever reducer

Dextromethorphan hydrobromide/Cough suppressant

Doxylamine succinate/Antihistamine

Phenylephrine hydrochloride/Nasal decongestant

Allergy & Cough

formula

Sinus Congestion & Pressure

Headache & Pain – Runny Nose & Sneezing

Itchy, Watery Eyes – Cough

COMPARE TO the active ingredients of Alka-Seltzer Plus® Severe Sinus Congestion Liquid Gels

20 Liquid Gels

(liquid filled capsules)

allergy and cough

Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55312-345
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
DOXYLAMINE SUCCINATE DOXYLAMINE 6.25 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
POVIDONES
propylene glycol
water

Product Characteristics

Color Size Imprint Code Shape
GREEN (clear green) 20 mm 345 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 BLISTER PACK
2 NDC:55312-345-60 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-03-28


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