Label: GILTUSS TR- guaifenesin,dextromethorphan hbr,phenylephrine hcl tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 66576-335-01 - Packager: Syntho Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 13, 2022
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- Official Label (Printer Friendly)
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Drug Facts
Active Ingredients (in each tablet) Guaifenesin 390 mg. Dextromethorphan HBr 29 mg. Phenylephrine HCl 10 mg.
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Purposes
Expectorant - Antitussive - Nasal Decongestant
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Uses
Temporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other - upper respiratory allergies. Helps loosen phlegm (mucus), loosens nasal congestion, thin ...
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Warnings
Do not use this product more than the recommended dosage, or if you are now taking a - prescription Monoamine Oxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or ...
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Ask a doctor before use if you have• heart disease. • excessive phlegm (mucus). • high blood pressure. • diabetes. • thyroid disease. • difficulty in urination due to enlargement of the prostate gland. • persistent or chronic cough ...
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Stop use and ask a doctor if:• nervousness, dizziness, or sleeplessness occurs. • symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus). • cough and congestion do not ...
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PREGNANCY OR BREAST FEEDINGIf pregnant or breast-feeding, ask a health professional before use - . Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison ...
- KEEP OUT OF REACH OF CHILDREN
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Directions
Do not exceed recommended doses in a 24 hour period - Adults and Children 12 years and over: 1 tablet every 6 to 8 hours. Do not exceed 4 tablets in 24 hours. Children 6 to 12 ...
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Other information
• store at room temperature, USP. • do not use if imprinted safety seal under cap is broken or missing.
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Inactive Ingredients
Hydroxypropyl Methylcellulose, Magnesium Stearate, Maltodextrin, Microcrystalline - Cellulose, Polyethylene Glycol, Povidone, Silicone Dioxide and Stearic Acid.
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Questions? Call 787-848-9114
Manufactured for: GIL PHARMACEUTICAL CORP., Ponce, Puerto Rico 00716 - Manufactured by: Syntho Pharmaceuticals, Inc ...
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELGiltuss - ® Total Release - NDC-66576-335-01 - 100's Bottle Label.
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INGREDIENTS AND APPEARANCEProduct Information