Label: ACETAMINOPHEN - acetaminophen tablet
- NDC Code(s): 0536-3233-07
- Packager: Rugby Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 10, 2012
If you are a consumer or patient please visit this version.
- Active Ingredient
(in each tablet)
Acetaminophen 80 mgClose
Pain Reliever/Fever ReducerClose
For the temporary relief of minor aches and pains due to:
- common cold
- sore throat
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.
Ask a doctor before use if your child has liver disease
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
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 appear
- redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
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.Close
- this product does not contain directions or complete warnings for adult use
- find correct dose below
- if possible use weight to dose, otherwise use age
- chew tablets before swallowing
- give dose every 4 hours while symptoms last
- do not give more than 5 doses in 24 hours
Weight Age Dose 72 - 95 lbs 11-12 years 4 – 6 tablets 60 - 71 lbs 9 - 10 years 4 – 5 tablets 48 - 59 lbs 6 - 8 years 4 tablets 36 - 47 lbs 4 - 5 years 3 tablets 24 - 35 lbs 2 - 3 years 2 tablets under 24 lbs under 2 years ask a doctor
- Other Information
- store at room temperature 15°-30°C (59°-86°F)
- Inactive Ingredients
citric acid, D&C Red #33, FD&C Red #40, glycerin, polyethylene glycol 1450, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose syrupClose
- Questions or Comments
Children's Pain & Fever is manufactured for Rugby Laboratories, Inc.
Duluth, Georgia 30097Close
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
18 mL Bottle Carton
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-3233 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. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) Product Characteristics Color PINK (Light Pink) Score 2 pieces Shape ROUND Size 10mm Flavor FRUIT (fruit flavor) Imprint Code AP;051 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-3233-07 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 08/12/2002 Labeler - Rugby Laboratories Inc. (191427277) Registrant - Advance Pharmaceutical Inc. (078301063) Establishment Name Address ID/FEI Business Operations Advance Pharmaceutical Inc. 078301063 MANUFACTURE(0536-3233)