Perrigo Children’s Pain Relief Drug Facts

Perrigo Children’s Pain Relief Drug Facts
SPL v1
SPL
SPL Set ID 45ddd71d-de6c-4e21-a22a-0b37afcc429b
Route
ORAL
Published
Effective Date 2013-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Butylparaben Carboxymethylcellulose Sodium Carrageenan D&c Red No. 33 Fd&c Blue No. 1 Glycerin High Fructose Corn Syrup Cellulose, Microcrystalline Propylene Glycol Water Sodium Benzoate Sorbitol Calcium Sulfate Sodium Phosphate, Tribasic

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1993-02-25

Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

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.

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 children 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.

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
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

For Ages 2 – 11

Children’s

Pain Relief

Acetaminophen Oral Suspension

Fever Reducer/Pain Reliever

Suspension Liquid

Alcohol Free

Aspirin Free

Ibuprofen Free

Grape Flavor

Compare to active ingredient of Children’s Tylenol® Oral Suspension

160 mg per 5 mL

Repackaged By :

Aidarex Pharmaceuticals LLC,

Corona, CA 92880

When Using This Product

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.

Ask A Doctor Before Use If Your Child Has

liver disease

Active Ingredient (in Each 5 Ml = 1 Teaspoon)

Acetaminophen 160 mg

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin


Structured Label Content

Uses

temporarily:

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

Pain reliever/fever reducer

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.

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 children 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.

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 your child has ever had an allergic reaction to this product or any of its ingredients
Other Information (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 (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? (Questions or comments?)

1-800-719-9260

Principal Display Panel

For Ages 2 – 11

Children’s

Pain Relief

Acetaminophen Oral Suspension

Fever Reducer/Pain Reliever

Suspension Liquid

Alcohol Free

Aspirin Free

Ibuprofen Free

Grape Flavor

Compare to active ingredient of Children’s Tylenol® Oral Suspension

160 mg per 5 mL

Repackaged By :

Aidarex Pharmaceuticals LLC,

Corona, CA 92880

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)

Stop Use and Ask A Doctor If (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. (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.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease

Active Ingredient (in Each 5 Ml = 1 Teaspoon) (Active ingredient (in each 5 mL = 1 teaspoon))

Acetaminophen 160 mg

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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