Childrens pain relief tablet, chewable

Active ingredient (in each tablet)

Acetaminophen USP 160 mg

Purpose

Pain reliever/fever reducer

Uses


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

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
  • Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:
    • skin reddening
    • blisters
    • rash.

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

  • 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 is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use ifyour child has

liver disease.

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 dosage.

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 (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children 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)
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours

Weight (lb)
Age (yr)
Dose (tablets)*
* or as directed by a doctor
under 24
under 2 years
ask a doctor
24-35
2-3 years
1 tablet
36-47
4-5 years
1 tablets
48-59
6-8 years
2 tablets
60-71
9-10 years
2 tablets
72-95
11 years
3 tablets

Other information


  • store at 20 to 25C (68 to 77F). Avoid high humidity.
  • Tamper Evident: Do not use if carton is open or if printed seal on blister is broken or missing.

Inactive ingredients

citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.


Questions or comments?

Call 1-855-274-4122


* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol ®Chewables.

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

Distributed by:Discount Drug Mart
211 Commerce Drive
Medina, OH 44256
www.discount-drugmart.com

Ingredients and appearance - Product information

Childrens pain relief tablet, chewable- Acetaminophen

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 53943-837
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 160 mgin 1

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Copovidone k25-31 ( UNII: D9C330MD8B)
Crospovidone (120 .mu.m) ( UNII: 68401960MK)
D&c red no. 27 ( UNII: 2LRS185U6K)
D&c red no. 30 ( UNII: 2S42T2808B)
Dextrose monohydrate ( UNII: LX22YL083G)
Ethylcellulose (4 mpa.s) ( UNII: KC5472WRJK)
Magnesium stearate ( UNII: 70097M6I30)
Mannitol ( UNII: 3OWL53L36A)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Stearic acid ( UNII: 4ELV7Z65AP)
Sucralose ( UNII: 96K6UQ3ZD4)

Product Characteristics

Color PINK Shape ROUND
Size 16 mm Score 2
Imprint Code F8 Flavor BUBBLE GUM

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part343 USA

Labeler - DISCOUNT DRUG MART( 047741335)

Establishment

Name ID/FEI Business Operations
DISCOUNT DRUG MART 047741335 MANUFACTURE( 53943-837)

Package label-principal display panel -160 mg(24 chewable tablets)

NDC 53943-837-76

*Compare to the active ingredient
in Children's Tylenol® Chewables
Ages 2-11
Children's Pain Relief
Acetaminophen 160 mg
Pain reliever/Fever reducer

  • Aspirin Free
  • Ibuprofen Free


Bubblegum Flavor

24
Chewable Tablets