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NDC 17714-0133-50 ACETAMINOPHEN PM 500; 25 mg/1; mg/1 Details
ACETAMINOPHEN PM 500; 25 mg/1; mg/1
ACETAMINOPHEN PM is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Advance Pharmaceutical Inc.. 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: 17714-0133-50Last 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: 17714-0133-50Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine
Product Information
| NDC | 17714-0133 |
|---|---|
| Product ID | 17714-133_60f41580-e074-faad-e053-2a91aa0a9076 |
| 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 | ACETAMINOPHEN PM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ACETAMINOPHEN PM |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 500; 25 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE |
| Labeler Name | Advance Pharmaceutical Inc. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 17714-0133-50 (17714013350)
| NDC Package Code | 17714-133-50 |
|---|---|
| Billing NDC | 17714013350 |
| Package | 50 TABLET in 1 BOTTLE (17714-133-50) |
| Marketing Start Date | 2002-01-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b172226e-8f2a-4d9c-b7c7-dd737b90463a 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
- 3 or more alcoholic drinks every day while using this product
do not use
- with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other drug containing diphenhydramine, even one used on skin
- in children under 12 years of age
Ask a doctor before use if the 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
- taking sedative 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 serious underlying medical illness.
- Any new symptoms appear
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed
- adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
- children under 12 years : do not use this adult product in children under 12 years of age; this will provide more than the recommended dose(overdose) and may cause liver damage
Inactive Ingredients
Questions or Comments
INGREDIENTS AND APPEARANCE
| ACETAMINOPHEN PM
acetaminophen pm tablet |
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| Labeler - Advance Pharmaceutical Inc. (078301063) |
| Registrant - Advance Pharmaceutical Inc. (078301063) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Advance Pharmaceutical Inc. | 078301063 | manufacture(17714-133) | |