Label: CHILDRENS PAIN RELIEF- acetaminophen tablet, chewable
- NDC Code(s): 59779-452-01
- Packager: CVS Pharmacy
- 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 September 26, 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
- sore throat
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.
- 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 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 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- protect from light
- 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, 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® Meltaways®†
ACETAMINOPHEN, 80 mg
Pain reliever, Fever reducer
• Aspirin free
• Ibuprofen free
Actual Product Size on Side Panel
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®.
CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy CVS.com®
1-800-SHOP CVS V-11112
- INGREDIENTS AND APPEARANCE
CHILDRENS PAIN RELIEF
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-452 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) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) DEXTRATES (UNII: G263MI44RU) 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:59779-452-01 1 in 1 CARTON 12/06/2004 04/03/2020 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 04/03/2020 Labeler - CVS Pharmacy (062312574) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(59779-452) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(59779-452) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(59779-452) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(59779-452) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(59779-452)