Label: CHILDRENS PAIN RELIEF- acetaminophen tablet, chewable
- NDC Code(s): 55910-447-01
- Packager: DOLGENCORP, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
(in each tablet)
Acetaminophen 80 mgClose
Pain reliever / fever reducerClose
- temporarily relieves minor aches and pains due to:
- the common cold
- temporarily reduces fever
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 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 warning for adult use
- find the right dose on chart. 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 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
- Other information
- store at controlled room temperature 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
- Inactive ingredients
citric acid, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrose, ethylcellulose, flavors, magnesium stearate, mannitol, polyethylene, povidone, stearic acid, sucraloseClose
- Questions or comments?
- Product Packaging
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
Compare to active ingredient in Children's Tylenol® Meltaways*
For Ages 2-11
SEE NEW WARNINGS INFORMATION
Pain Reliever / Fever Reducer
• Ibuprofen free
• Aspirin free
Bubble Gum Flavor
DG Quality Guaranteed
80 mg Tablets
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSIONS RIDGE
GOODLETTSVILLE, TN 37073
- INGREDIENTS AND APPEARANCE
CHILDRENS PAIN RELIEF
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55910-447 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 80 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE D&C RED NO. 27 D&C RED NO. 30 DEXTROSE ETHYLCELLULOSES MAGNESIUM STEARATE MANNITOL POVIDONE STEARIC ACID SUCRALOSE 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:55910-447-01 1 in 1 CARTON 1 30 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 02/03/2005 Labeler - DOLGENCORP, LLC (068331990)