Label: PAIN AND FEVER- acetaminophen tablet, chewable
- NDC Code(s): 0536-1014-07
- Packager: RUGBY LABORATORIES
- 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 7, 2019
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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 other drug containing acetaminophen (prescription or non prescription). 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.
DOSAGE & ADMINISTRATION
- this product does not contain directions or warnings for adult use.
- find right dose on chart below. If possible, use weight to dose; otherwise use age.
- 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 more than 5 days unless directed by a doctor
Weight Age Dosage Under 24 lbs Under 2 years Ask a doctor 24-35 lbs 2-3 years 2 tablets 36-47 lbs 4-5 years 3 tablets 48-59 lbs 6-8 years 4 tablets 60-71 lbs 9-10 years 5 tablets 72-95 lbs 11 years 6 tablets
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
PAIN AND FEVER
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1014 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 ASPARTAME (UNII: Z0H242BBR1) D&C RED NO. 27 (UNII: 2LRS185U6K) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color pink Score no score Shape ROUND (ROUND BICONVEX TABLET) Size 10mm Flavor BERRY (Natural and Artificial) Imprint Code 1G Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1014-07 1 in 1 CARTON 12/01/2013 05/31/2021 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 12/01/2013 05/31/2021 Labeler - RUGBY LABORATORIES (079246066) Registrant - Gemini Pharmaceuticals, Inc. (055942270) Establishment Name Address ID/FEI Business Operations Gemini Pharmaceuticals, Inc. 055942270 manufacture(0536-1014)