Label: CHILDRENS ACETAMINOPHEN- acetaminophen tablet, chewable
- NDC Code(s): 64092-031-20
- Packager: GREAT LAKES WHOLESALE, MARKETING, & SALES, 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 January 25, 2018
If you are a consumer or patient please visit this version.
- Active ingredient (in each tablet)
Acetaminophen 80 mgClose
Pain reliever/fever reducerClose
- temporarily relieves minor aches and pains due to:
- the common cold
- sore throat
- temporarily reduces fever
- temporarily relieves minor aches and pains due to:
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
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
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.
In case of accidental 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.
- this product does not contain directions or complete warnings for adult use
- do not give more than directed
- 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 than 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
- store at 25°C (77°F); 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 hydrated, ethylcellulose, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucraloseClose
- Questions or comments?
- Principal Display Panel
†Compare to the active ingredient in
Children's Tylenol® Meltaways®
Pain Reliever • Fever Reducer
Aspirin Free • Ibuprofen Free
20 Chewable 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®.
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.
Grand Rapids, MI 49512
If you are not completely satisfied with this
product, regardless of reason, return your unused
portion to Great Lakes Wholesale for a full refund
- INGREDIENTS AND APPEARANCE
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64092-031 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) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) Product Characteristics Color PINK Score no score Shape ROUND Size 13mm Flavor BUBBLE GUM Imprint Code 44;447 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64092-031-20 1 in 1 CARTON 02/03/2005 11/28/2020 1 20 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 02/03/2005 11/28/2020 Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(64092-031) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(64092-031) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(64092-031) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(64092-031) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(64092-031)