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| Product NDC Code | 68016-029 | ||||
|---|---|---|---|---|---|
| Drug Name | Extra strength pain relief |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, COATED | ||||
| RxCUI drug identifier | 198440 | ||||
| Application Number | M013 | ||||
| Labeler Name | Chain Drug Consortium, LLC | ||||
| 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 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.Directions Do not take more than directed (see overdose warnings) Adults and children 12 years and over Take 2 gelcaps every 4-6 hours, as needed. Do not take more than 8 gelcaps in 24 hours Children under 12 years Do not use
| Adults and children 12 years and over |
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| Children under 12 years | Do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients croscarmellose sodium, D&C Red #33, FD&C Blue #1, FD&C Red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide, PEG, povidone, propylene glycol, shellac glaze, starch, stearic acid, titanium dioxide.
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 temporarily relieves minor aches and pains due to: - headache - muscular aches - backache - arthritis - the common cold - toothache - 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.Extra Strength Pain Relief Acetaminophen CROSCARMELLOSE SODIUM D&C RED NO. 33 FD&C BLUE NO. 1 GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL STARCH, CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN TITANIUM DIOXIDE FD&C RED NO. 40 HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES FERRIC OXIDE RED SHELLAC Gelcap L;5 with blue and a gray band
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.package label NDC 68016-029-47 Compare to active ingredient in Extra Strength Tylenol Rapid Release Gels* Extra Strength PAIN RELIEF ACETAMINOPHEN Rapid Release Pain Reliever/ Fever Reducer Gelcaps 400 Gelcaps 500 mg each 251 label
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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. store at controlled room temperature 20⁰C-25⁰C (68⁰F-77⁰F) avoid high humidity Inactive Ingredients croscarmellose sodium, D&C Red #33, FD&C Blue #1, FD&C Red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide, PEG, povidone, propylene glycol, shellac glaze, starch, stearic acid, titanium dioxide.
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 gelcaps in 24 hours, which is the maximum daily amount 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are t aking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptom occur redness or swelling is present These could be signs of a serious condition. 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Keep out of reach of children.
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