Label: NON-ASPIRIN CHILDRENS- acetaminophen tablet, chewable
- NDC Code(s): 63868-186-24
- Packager: CHAIN DRUG MARKETING ASSOCIATION 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 August 15, 2017
If you are a consumer or patient please visit this version.
- Active ingredient (in each tablet)
Acetaminophen 160 mgClose
Pain reliever/fever reducerClose
- temporarily relieves minor aches and pains due to:
- sore throat
- the common cold
- 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 1 36-47 4-5 1 1/2
48-59 6-8 2 60-71 9-10 2 1/2 72-95 11 3
*or as directed by a doctorClose
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid high humidity
- see end flap for expiration date and lot number
- Inactive ingredients
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucraloseClose
- Questions or comments?
- Principal display panel
†Compare to the active ingredient in Children's Tylenol®
Acetaminophen, 160 mg
Pain Reliever / Fever Reducer
Ibuprofen Free ι Aspirin Free
Pain / Fever
24 CHEWABLE TABLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY: C.D.M.A., Inc. ©
43157 W 9 Mile Rd
Novi, MI 48375
**This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of the
registered trademark Children's Tylenol®.
Quality Choice 44-449
- INGREDIENTS AND APPEARANCE
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-186 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (UNII: 2S7830E561) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C RED NO. 30 (UNII: 2S42T2808B) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) Product Characteristics Color PURPLE Score 2 pieces Shape ROUND Size 16mm Flavor GRAPE Imprint Code 44;449 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-186-24 1 in 1 CARTON 01/28/2005 1 24 in 1 BOTTLE; 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 01/28/2005 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(63868-186) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(63868-186) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(63868-186) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(63868-186) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(63868-186)