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NDC 00135-7021-03 PANADOL 500; 25 mg/1; mg/1 Details
PANADOL 500; 25 mg/1; mg/1
PANADOL is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 00135-7021-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 00135-7021-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 00135-7021 |
|---|---|
| Product ID | 0135-7021_b9015bb7-f72e-4ab6-833e-82e5603986b2 |
| Associated GPIs | |
| 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 | PM |
| Non-Proprietary Name | acetaminophen and diphenhydramine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500; 25 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00135-7021-03 (00135702103)
| NDC Package Code | 0135-7021-03 |
|---|---|
| Billing NDC | 00135702103 |
| Package | 1 BOTTLE in 1 CARTON (0135-7021-03) / 50 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2021-12-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL fe7cd1f2-9b00-4ded-99c2-8a152c71093c Details
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 4,000 mg of acetaminophen in 24 hours
- •
- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert:
acetaminophen may cause severe skin reactions. Symptoms may include:
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- 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.
- •
- with any other product containing diphenhydramine, even one used on skin
- •
- in children under 12 years of age
- •
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
- •
- liver disease
- •
- glaucoma
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking
- •
- the blood thinning drug warfarin
- •
- sedatives or tranquilizers
When using this product
- •
- drowsiness will occur
- •
- avoid alcoholic drinks
- •
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- •
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- •
- pain gets worse or lasts more than 10 days
- •
- redness or swelling is present
- •
- any new symptoms appear
These could be signs of a serious condition.
Directions
Inactive ingredients
Additional Information (2 caplets)
Additional Information ((24 and 50 caplets)
Principal Display Panel
NDC 0135-7021-03
Panadol
EXTRA STRENGTH
PM
ACETAMNOPHEN
Pain Reliever
DIPHENHYDRAMINE HCl
Nighttime Sleep-Aid
50 CAPLETS
Tamper-Evident Feature: Do not use if printed inner safety seal under cap is broken or missing.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
Dist. by: GSKConsumer Healthcare
Warren, NJ 07059
Trademarks owned or licensed by GSK.
©2021 GSK or licensor.
B-0630-765-08 ORG
INGREDIENTS AND APPEARANCE
| PANADOL
PM
acetaminophen and diphenhydramine hcl tablet, film coated |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |