Label: NON-ASPIRIN JUNIOR STRENGTH- acetaminophen tablet, chewable
- NDC Code(s): 63868-158-24
- 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 February 8, 2019
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- Active ingredient (in each tablet)
Acetaminophen 160 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
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.
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.
- 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.
- dissolve in mouth or chew before swallowing
- if needed, 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) Tablets Under 48 Under 6 Ask a doctor 48-59 6-8 2 60-71 9-10 2 1/2 72-95 11 3
- Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- 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?
- Product Packaging
*Compare to the
active ingredient in
Acetaminophen, 160 mg
Pain Reliever / Fever Reducer
Ibuprofen Free | Aspirin Free
Grape Flavored Rapid Melts
24 TABLETS (160 mg each)
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Junior Strength Tylenol® Meltaways®.
©DISTRIBUTED BY C.D.M.A., Inc.
43157 W. Nine Mile
Novi, MI 48376-0995
Quality Choice 44-449
- INGREDIENTS AND APPEARANCE
NON-ASPIRIN JUNIOR STRENGTH
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-158 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX) 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) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) 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:63868-158-24 4 in 1 CARTON 01/28/2005 09/26/2020 1 6 in 1 BLISTER PACK; 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 09/26/2020 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(63868-158) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(63868-158) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(63868-158) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(63868-158) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(63868-158)