Children's Pain & Fever 526

Children's Pain & Fever 526
SPL v5
SPL
SPL Set ID 2aa0f9f3-924c-4a4a-bb5f-2a326acc2408
Route
ORAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-04

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 maxium daily amount
  • with other drugs containing acteaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stopuse and seek medical help right away.

Sore throat warning: If a sore throat is severe, persiss for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Questions

Call weekays from 9:30 AM to 4:30 PM

Directions
  • this product does not contain directions or complete warnings for adult use.
  • shake well before using
  • mL = millititer; tsp = teaspoonful
  • find right dose on chart below. If possible, use weight to dose, otherwise, use age.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give for more than 5 days unless directed by a doctor

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 1/2 tsp)

48-59               6-8 years           10 mL (2 tsp)

60-71               9-10 years          12.5 mL (2 1/2 tsp)

72-95               11 years              15 mL

* or as directed by a doctor

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

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 is allergic to acetaminophen or to any of the inactive ingredients in this product
Drug Facts

Acetaminophen 160 mg

Overdose Warning

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.

Other Information
  • eash 5mL (1 tsp) contains sodium 3mg
  • store between 20-25
Inactive Ingrediants

anhydrous citric acid, butylparaben, D&C Red # 33, FD&C (red), flavor, glycerin, flavor, high frucotose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum   

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.

Ask A Doctor If Your Child Has

liver disease

Keep Out of Reach of Children.

Keep out of reach of children.

Children's Pain & Fever Product Label

DISCOUNT

drug mart

FOOD FAIR

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S TYLENOL® ORAL SUSPENSION

Fever Reducer / Pain Reliever

Children's Pain & Fever

Acetaminophen Oral Suspension

  • Alcohol-Free
  • Ibuprofen Free
  • Aspirin Free

For Ages 2 to 11

GRAPE FLAVOR

4 FL OZ (118 mL)

160 mg per 5 mmL

* This product is not manufactures or distributed by McNeil Consumer Healthcare, distribbutor of Children's Tylenol® Oral Suspension.

BX-053

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STOORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

res

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.

When Using This Product Do Not Exceed Recommended Dose.

(see overdose warnings)


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 maxium daily amount
  • with other drugs containing acteaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stopuse and seek medical help right away.

Sore throat warning: If a sore throat is severe, persiss for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Questions

Call weekays from 9:30 AM to 4:30 PM

Directions
  • this product does not contain directions or complete warnings for adult use.
  • shake well before using
  • mL = millititer; tsp = teaspoonful
  • find right dose on chart below. If possible, use weight to dose, otherwise, use age.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give for more than 5 days unless directed by a doctor

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 1/2 tsp)

48-59               6-8 years           10 mL (2 tsp)

60-71               9-10 years          12.5 mL (2 1/2 tsp)

72-95               11 years              15 mL

* or as directed by a doctor

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

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 is allergic to acetaminophen or to any of the inactive ingredients in this product
Drug Facts

Acetaminophen 160 mg

Overdose Warning (Overdose warning)

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.

Other Information (Other information)
  • eash 5mL (1 tsp) contains sodium 3mg
  • store between 20-25
Inactive Ingrediants (Inactive ingrediants)

anhydrous citric acid, butylparaben, D&C Red # 33, FD&C (red), flavor, glycerin, flavor, high frucotose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum   

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.

Ask A Doctor If Your Child Has (Ask a doctor if your child has)

liver disease

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.

Children's Pain & Fever Product Label (Children's Pain & Fever product label)

DISCOUNT

drug mart

FOOD FAIR

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S TYLENOL® ORAL SUSPENSION

Fever Reducer / Pain Reliever

Children's Pain & Fever

Acetaminophen Oral Suspension

  • Alcohol-Free
  • Ibuprofen Free
  • Aspirin Free

For Ages 2 to 11

GRAPE FLAVOR

4 FL OZ (118 mL)

160 mg per 5 mmL

* This product is not manufactures or distributed by McNeil Consumer Healthcare, distribbutor of Children's Tylenol® Oral Suspension.

BX-053

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STOORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

res

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.

When Using This Product Do Not Exceed Recommended Dose. (When using this product do not exceed recommended dose.)

(see overdose warnings)


Advanced Ingredient Data


Raw Label Data

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