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NDC 00135-0539-02 PANADOL 160 mg/5mL Details
PANADOL 160 mg/5mL
PANADOL is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is ACETAMINOPHEN.
Product Information
| NDC | 00135-0539 |
|---|---|
| Product ID | 0135-0539_be98c798-4afe-4975-9936-b3bca28e2bd7 |
| Associated GPIs | 64200010001840 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | PANADOL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 160 |
| Active Ingredient Units | mg/5mL |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00135-0539-02 (00135053902)
| NDC Package Code | 0135-0539-02 |
|---|---|
| Billing NDC | 00135053902 |
| Package | 1 BOTTLE in 1 CARTON (0135-0539-02) / 54.7 mL in 1 BOTTLE |
| Marketing Start Date | 2012-10-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 95801755-db54-4ad7-bec1-52671914f6ca Details
Uses
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:
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- skin reddening
- •
- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
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- 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
Directions:
this product does not contain directions or complete warnings for adult use
- •
- do not take more than directed (see overdose warning)
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- 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
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- do not take more than 5 doses in 24 hours, unless directed by a doctor
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- use only with enclosed pre-marked measuring syringe 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 |
Inactive ingredients
Principal Display Panel
NDC 0135-0539-02
Panadol®
Infants’
ACETAMINOPHEN
160 mg per 5 mL
LIQUID
Pain Reliever
Fever Reducer
SEE NEW WARNINGS INFORMATION
Ages 2-3 years
Fast relief of fever and pain
Gentle on your stomach
- •
- Ibuprofen free
- •
- No sugar added
- •
- Aspirin free
artificial
raspberry flavor
Dosing Device Inside
l.85 fl oz (54.7 mL)
Tamper Evident Feature: Do not use if printed overwrap is missing or broken.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
GlaxoSmithKline Consumer Healthcare, L.P.
Moon Township, PA 15108
Made in Canada
©2015 GSK
All Rights Reserved.
USING THE CONVENIENT DOSING DEVICE
- •
- Shake the bottle well. Push the dosing device firmly into the bottle’s neck.
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- Turn the bottle upside down. Holding the device in place, gently pull the plunger out to draw the correct dose.
- •
- With the bottle in an upright position, remove the device from the plug and bottle by gently pulling it. Place the end of the device into the child’s mouth. Administer dose by pressing the plunger slowly.
After use, replace the cap. Wash the device in warm water and allow to dry.
PANADOL, the Beacon design and the Bear design are registered trademarks of the GSK group of companies.
Keep Carton
102012XB (A134044)
INGREDIENTS AND APPEARANCE
| PANADOL
acetaminophen suspension |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |