Indications and uses
temporarily relieves minor aches and pains due to: colds flu headache toothache temporarily reduces fever
PANADOL
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2024-02-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 14
- Source
- full-release
- Hydrated at
- 2026-06-01 00:08:22
Label at a glance#
ProductPANADOL
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
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 ...
Storage and handling
store below 30°C (86°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each 5mL)
Acetaminophen 160 mg
Purposes
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- colds
- flu
- headache
- toothache
- temporarily reduces fever
Warnings
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
- blisters
- rash
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
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
- redness or swelling is present
- any new symptoms appear
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning:
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.
Directions:
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.
Age | Weight | Dosage |
under 2 yrs | under 24 lbs | ask a doctor |
2 - 3 yrs | 24 – 35 lbs | 5 mL* |
4 – 5 yrs | 36 – 47 lbs | 7.5 mL |
6 – 8 yrs | 48 – 59 lbs | 10 mL |
9 – 10 yrs | 60 – 71 lbs | 12.5 mL |
11 yrs | 72 – 95 lbs | 15 mL |
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 ingredients
Questions or comments?
1-800-455-7139(English/Spanish) weekdays
Principal Display Panel
NDC 0135-0537-03
Panadol ®
Children’s
ACETAMINOPHEN
160 mg per 5 mL
LIQUID
SPain Reliever
Fever Reducer
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
artificial
raspberry flavor
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.
GlaxoSmithKlineConsumer Healthcare, L.P.
Moon Township, PA 15108
Made in Canada
©2015 GSK
All Rights Reserved.
Keep Carton
102003XB
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0537-01 | PANADOL | 15 mL in 1 BOTTLE | SUSPENSION | 15 | 14 | |
| 0135-0537-01 | PANADOL | 1 in 1 CARTON | SUSPENSION | 1 | 14 | |
| 0135-0537-02 | PANADOL | 54.7 mL in 1 BOTTLE | SUSPENSION | 54.7 | 14 | |
| 0135-0537-02 | PANADOL | 1 in 1 CARTON | SUSPENSION | 1 | 14 | |
| 0135-0537-03 | PANADOL | 1 in 1 CARTON | SUSPENSION | 1 | 14 | |
| 0135-0537-03 | PANADOL | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 14 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0537-03 | ML - Milliliter | 0135-0537 | 4d37b28e-b7a6-4ed1-a89f-c37b76e475d4 | 1 | 2022-12-07 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 8 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 8 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | 8 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 8 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 8 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | 8 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | 8 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 8 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 8 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 8 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 8 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 8 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 8 |
Products#
Every source-derived product name is available through these pages.
- PANADOL
- acetaminophen
- BENZOIC ACID
- FD&C RED NO. 40
- GLYCERIN
- HYDROCHLORIC ACID
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POTASSIUM SORBATE
- PROPYLENE GLYCOL
- WATER
- SODIUM HYDROXIDE
- SACCHARIN SODIUM
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0135-0537 | 0135-0537-01, 0135-0537-02, 0135-0537-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBITOL | 506T60A25R | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SUSPENSION / ORAL | 15 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SUSPENSION / ORAL | 15 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION / ORAL | 100 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SUSPENSION / ORAL | 15 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION / ORAL | 100 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ORAL | 400 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SUSPENSION / ORAL | 15 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION / ORAL | 100 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ORAL | 400 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION / ORAL | 100 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ORAL | 400 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION / ORAL | 100 mg/5ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ORAL | 400 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PANADOL | ACETAMINOPHEN | Haleon US Holdings LLC | e1799765-c247-42b4-ad6a-8ba7d136abf2 | 2024-02-06 | Warnings | 0135-0537-02 0135-0537-03 0135-0537-01 0135-0537 00135053702 00135053703 00135053701 10c0504e-269e-b058-e063-6394a90a5b84 e1799765-c247-42b4-ad6a-8ba7d136abf2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.