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

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg


Medication Information

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.

Uses

temporarily:

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

Pain reliever/fever reducer

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.

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

Description

Acetaminophen 160 mg

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

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
Questions Or Comments?

1-800-719-9260

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

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.

Uses

temporarily:

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

Pain reliever/fever reducer

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.

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

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

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
Questions Or Comments? (Questions or comments?)

1-800-719-9260

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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