Label: PANADOL- acetaminophen suspension
- NDC Code(s): 0135-0537-01, 0135-0537-02, 0135-0537-03
- Packager: GlaxoSmithKline Consumer Healthcare LP
- 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 8, 2016
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- Active ingredient (in each 5mL)
Acetaminophen 160 mgClose
Pain reliever/fever reducerClose
temporarily relieves minor aches and pains due to:
- 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
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.
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 you are 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
- redness or swelling is present
- any new symptoms appear
These could be signs of a serious condition.
Taking more than the recommended dose can cause serious health problems. In case of oversdose, 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 warnings for adult use
- do not take more than directed (see overdose warning)
- find right dose in chart. If possible use weight to dose; otherwise, use age
- if needed, repeat dose every 4 hours while symptoms persist or as directed by a doctor
- do not take more than 5 doses in 24 hours, unless directed by a doctor
- use only with enclosed pre-marked measuring cup for accuracy. Do not use any other dosing device.
under 2 yrs
under 24 lbs
ask a doctor
2 - 3 yrs
24 – 35 lbs
4 – 5 yrs
36 – 47 lbs
6 – 8 yrs
48 – 59 lbs
9 – 10 yrs
60 – 71 lbs
72 – 95 lbs
- Other information
- store below 30°C (86°F)
- Inactive ingredients
benzoic acid, FD&C red no. 40, flavor, glycerin, hydrochloric acid*, polyethylene glycol, potassium sorbate, propylene glycol, purified water, sodium hydroxide*, sodium saccharin, sorbitol solution
*contains one or more of these ingredientsClose
- Questions or comments?
1-800-455-7139 (English/Spanish) weekdaysClose
- Principal Display Panel
160 mg per 5 mL
EE NEW WARNINGS INFORMATION
Ages 2-11 years
Fast relief of fever and pain
Gentle on your stomach
- Ibuprofen free
- No sugar added
- Aspirin free
4 fl oz (118 mL)
Tamper Evident Feature: Do not use if printed overwrap is missing or broken.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
PANADOL, the Beacon design and the Bear design are registered trademarks of the GSK group of companies.
GlaxoSmithKline Consumer Healthcare, L.P.
Moon Township, PA 15108
Made in Canada
All Rights Reserved.
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0537 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HYDROCHLORIC ACID (UNII: QTT17582CB) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) Product Characteristics Color RED (light red) Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0537-01 1 in 1 CARTON 10/15/2012 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0135-0537-02 1 in 1 CARTON 10/15/2012 2 54.7 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0135-0537-03 1 in 1 CARTON 10/15/2012 3 118 mL in 1 BOTTLE; 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 10/15/2012 Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)