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childrens pain and fever

WALGREEN COMPANY

Walgreen Co. Children’s Pain & Fever Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

childrens pain and fever Uses

temporarily:

  • •reduces fever
  • •relieves minor aches and pains due to:
  • •the common cold
  • •flu
  • •headache
  • •sore throat
  • •toothache

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • •more than 5 doses in 24 hours, which is the maximum daily amount
  • •with other drugs containing acetaminophen

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

  • •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 your child has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if your child has

liver disease

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin

When using

do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

  • •pain gets worse or lasts more than 5 days
  • •fever gets worse or lasts more than 3 days
  • •new symptoms occur
  • •redness or swelling is present

These could be signs of a serious condition.

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 even if you do not notice any signs or symptoms.

Directions

  • •this product does not contain directions or complete warnings for adult use
  • •do not give more than directed (see overdose warning)
  • •shake well before using
  • •mL = milliliter; tsp = teaspoonful
  • •find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • •remove the child protective cap and squeeze your child’s dose into the dosing cup
  • •repeat dose every 4 hours while symptoms last
  • •do not give more than 5 times in 24 hours

Weight (lb)

Age (yr)

Dose (mL or tsp)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL (1 tsp)

36-47

4-5 years

7.5 mL (1 ½ tsp)

48-59

6-8 years

10 mL (2 tsp)

60-71

9-10 years

12.5 mL (2 ½ tsp)

72-95

11 years

15 mL (3 tsp)

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

  • •each 5 mL (1 tsp) contains: sodium 3 mg
  • • store at 20-25°C (68-77°F)
  • •do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

Questions or comments?

1-800-719-9260

Principal Display Panel

children’s Pain & Fever

Acetaminophen

Pain Reliever / Fever Reducer

Oral Suspension

Alcohol free

Aspirin free

Ibuprofen free

Ages 2 to 11

4 FL OZ (118 mL)

160 mg per 5 mL

GRAPE FLAVOR

Compare to Children’s Tylenol® Oral Suspension active ingredient

childrens pain and fever

Acetaminophen SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-0212
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS CITRIC ACID
BUTYLPARABEN
CARRAGEENAN
D&C RED NO. 33
FD&C BLUE NO. 1
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
cellulose, microcrystalline
CARBOXYMETHYLCELLULOSE SODIUM
propylene glycol
water
SODIUM BENZOATE
sorbitol
SODIUM PHOSPHATE, TRIBASIC
CALCIUM SULFATE

Product Characteristics

Color
PURPLE (viscous)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 148 in 1 BOTTLE
3 NDC:0363-0212-28 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1995-10-13


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