Label: CALMADOL PAIN RELIEVER- naproxen sodium tablet
- NDC Code(s): 48201-007-24
- Packager: GRANDALL DISTRIBUTING, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 23, 2024
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Active Ingredients (in each tablet)Naproxen sodium 220 mg - (naproxen 200 mg)(NSAID)*
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PurposePain reliever/ fever reducer
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Uses■ temporarily relieves minor aches and pains due to: ■ headache ■ common cold ■ muscular aches - ■backache ■ toothache ■ menstrual cramps - ■minor pain of arthritis - ■temporarily reduces fever
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PREGNANCY OR BREAST FEEDINGIf pregnant or breast-feeding, ask a health professional before use. It is especially - important not to use naproxen sodium during - the last 3 months of pregnancy unless - definitely directed to do so ...
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KEEP OUT OF REACH OF CHILDREN.In case of overdose, get medical help or contact a Poison Control Center right away.
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WarningsAllergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock ■ skin ...
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Directions■ do not take more than directed - ■ the smallest effective dose should be used - ■ drink a full glass of water with each dose - ■ adults and children 12 years and older: take 1 tablet every 8 to 12 ...
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Other information:Each tablet contains sodium 20 mg. Store at 20-25 C (68-77ºF) Avoid high humidity and excessive heat above 40ºC (104ºF). Keep Carton.
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QuestionsIf you have questions of a medical nature, please conact your pharmacist, doctor or health care professional.
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SPL UNCLASSIFIED SECTIONDistributed by: Grandall Distributing Co., Inc. Glendale, CA 91204-2707
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Inactive ingredientscolloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline, cellulose, polyethylene glycol, povidone, titanium dioxide
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Package LabelingCALMADOL - PAIN RELIEVER - FEVER REDUCER - Naproxen Sodium Tablets - 220 mg (NSAID) 24 TABLETS
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INGREDIENTS AND APPEARANCEProduct Information