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Product NDC Code | 51824-061 | ||||
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Drug Name | Careall acetaminophen |
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Type | Brand | ||||
Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET | ||||
RxCUI drug identifier | 313782 | ||||
Application Number | M013 | ||||
Labeler Name | New World Imports, Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Acetaminophen 325mg
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.Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours while symptoms last. Do not take more than 10 tablets in 24 hours, unless directed by a doctor. do not take for more than 10 days unless directed by a doctor. Children 6-11 years of age: Take 1 tablet every 4 to 6 hours while symptoms last. Do not take more than 5 tablets in 24 hours. Do not use more than 5 days unless directed by a doctor. Children under 6 years of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
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.Uses Temporary relief of minor aches and pains associated with: headache, muscular aches, backache, minor pain from arthritis, the common cold, toothache, premenstrual and menstrual cramps Temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever / Fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.CareALL Acetaminophen Acetaminophen Acetaminophen Acetaminophen Starch, Corn Stearic Acid Povidone SODIUM STARCH GLYCOLATE TYPE A CORN white Round Circle AZ;010
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.image ACT32524
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 Reach of Children Keep out of reach of children. Overdose warning: In case of overdose, contact a doctor or Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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.Liver warning: This product contains acetaminophen. The manxium daily dose of this product is 10 tablets (3,250 mg) in 24 hours fro adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if: Adult takes more than 4,000mg of acetaminphen in 24 hours Child takes more than 5 doses in 24 hours Taken with other drugs containing acetaminophen Adult has 3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening, blisters or 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 allergic to acetaminophen. Ask a doctor before use if user has: liver disease Ask a doctor or pharmacist before use if: the user is taking the blood thinnig drug warfarin. is a child with pain of arthritis Stop use and ask a doctor if: Adults pain gets worse or lasts for more than 10 days. Childs pain gets worse or last fr more than 5 days. Fever gets worse or lasts for more than 3 days. New symptoms occur. Redness or swelling is present. If pregnant or breast-feeding, ask a health professional before use. 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 (1-800-222-1222) right away. Quick medical action is critical for adults as well as for children, even if you do not notice any signs or symptoms.
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