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| Product NDC Code | 49483-342 | ||||||||
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| Drug Name | Acetaminophen |
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| Type | Generic | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | TABLET, FILM COATED | ||||||||
| RxCUI drug identifier | 198440 | ||||||||
| Application Number | part343 | ||||||||
| Labeler Name | TIME CAP LABORATORIES, INC | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Each tablet contains Acetaminophen 500 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Do not take more than directed (see overdosage warning) Adults and children 12 years and over: take 2 tablets (1,000 mg) every 6 hours while symptoms last; do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor; do not take for more than 10 days unless directed by a doctor Children under 12 years: Do not use this adult extra strength product in children under 12 years of age, this will provide more than the recommended dose (overdosage) of acetaminophen and may cause liver damage
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.CARNAUBA WAX, FD-C RED NO. 40 ALUMINUM LAKE, HYPROMELLOSE, POLYETHYLENE GLYCOL(PEG) 400, POLYETHYLENE GLYCOL (peg) 8000, POVIDONE, PREGELATINIZED STARCH, SODIUM STARCH GLYCOLATE**, STEARIC ACID, SUCRALOSE, TITANIUM DIOXIDE ** MAY CONTAIN THIS INGREDIENT
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Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE: Pain Reliever – temporarily relieves minor aches and pains due to: the common cold, headache, backache, muscular aches, toothache, premenstrual and menstrual cramps, minor pain of arthritis. Temporarily reduces fever.
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Purpose
Information about the drug product’s indications for use.PURPOSE: Pain Reliever - fever reducer
| PURPOSE: Pain Reliever - fever reducer |
Spl product data elements
Usually a list of ingredients in a drug product.ACETAMINOPHEN ACETAMINOPHEN CARNAUBA WAX FD&C RED NO. 40 HYPROMELLOSES POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 8000 POVIDONE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID SUCRALOSE TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN TCL342
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.342LABEL
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep Out of the Reach of Children: In case of overdose, get medical help or contact a Poison Control Center right away
| Keep Out of the Reach of Children: In case of overdose, get medical help or contact a Poison Control Center right away |
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings; Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:more than 8 tablets in 24 hours, which is the maximum daily amount; 3 or more alcoholic drinks every day while using this product; with other drugs containing acetaminophen. Overdose warning: Taking more than the recommended dose (0verdose) may cause liver damage. in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1221) right way. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
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Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API