Label: COLD AND SINUS PAIN RELIEF tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 71105-106-68 - Packager: Redicare LLC
- 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 July 2, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Active Ingredients (in each tablet) .........................................Purpose
Acetaminophen 325 mg ........................................................................................................pain reliever/fever reducer
Guaifenesin 200 mg .....................................................................................................................................expectorant
Phenylephrine HCI 5 mg ...........................................................................................................................decongestant
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Uses:
temporarily: ■ relieves nasal congestion associated with sinusitis ■ relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies ■ relieves sinus congestion and pressure, helps decongest sinus openings and passages ■ restores freer breathing ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive. Temporarily relieves minor aches, pains, and fever associated with: ■ headache ■ common cold ■ toothache ■ backache ■ muscular aches ■ menstrual cramps
- Warnings:
- Liver Warning:
- Allergy Warning:
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Do not use:
■ with any other product containing acetaminophen; this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ when using this product do not exceed recommended dose ■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping MAOI drug. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product.
- Ask a doctor or pharmacist before use if:
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Stop use and ask a doctor if:
■ symptoms do not improve ■ pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present ■ nervousness, dizziness or sleeplessness occur ■ symptoms do not improve within 7 days or are accompanied by a fever • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.
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Ask a doctor before use if you have:
■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ difficulty in urination due to enlargement of the prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
- If pregnant or breast-feeding baby,
- KEEP OUT OF REACH OF CHILDREN.
- Directions:
- Other Information
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COLD AND SINUS PAIN RELIEF
cold and sinus pain relief tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71105-106 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color pink (Rose Pink) Score no score Shape ROUND Size 12mm Flavor CHERRY Imprint Code fr8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71105-106-68 100 in 1 CARTON; Type 0: Not a Combination Product 10/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/01/2017 Labeler - Redicare LLC (800149346)