Label: CHILDRENS PAIN RELIEF- acetaminophen tablet, chewable
- NDC Code(s): 41250-452-01
- Packager: Meijer Distribution Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated February 18, 2017
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- Active ingredient (in each tablet)
Acetaminophen 80 mgClose
Pain reliever/fever reducerClose
- temporarily reduces fever
- temporarily relieves minor aches and pains due to:
- the common cold
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
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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. Quick medical attention is critical even if you do not notice any signs or symptoms.
- do not give more than directed (see overdose warning)
- this product does not contain directions or complete warnings for adult use
- find the 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 athan 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor
Weight (lb) Age (yr) Dose (tablets)* Under 24 Under 2 Ask a doctor 24-35 2-3 2 36-47 4-5 3 48-59 6-8 4 60-71 9-10 5 72-95 11 6
*or as directed by a doctorClose
- Other information
- protect from light
- store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
- avoid high humidity
- Inactive ingredients
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucraloseClose
- Questions or comments?
- Product Packaging
Compare to Children's Tylenol® Meltaways®
For Ages 2 to 6
Acetaminophen • Pain Reliever/Fever Reducer
30 Tablets-80 mg Each
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Meltaways®. 50844 REV1013A45201
DIST. BY MEIJER
GRAND RAPIDS, MI 49544
- INGREDIENTS AND APPEARANCE
CHILDRENS PAIN RELIEF
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-452 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 30 (UNII: 2S42T2808B) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) DEXTRATES (UNII: G263MI44RU) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) Product Characteristics Color PURPLE Score no score Shape ROUND Size 13mm Flavor GRAPE Imprint Code 44;452 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-452-01 1 in 1 CARTON 12/06/2004 12/01/2019 1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 12/06/2004 12/01/2019 Labeler - Meijer Distribution Inc (006959555) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(41250-452) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(41250-452)