Label: COLDTAC PLUS- acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 69517-143-06, 69517-143-72 - Packager: Healthlife of USA
- 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 October 2, 2017
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- Official Label (Printer Friendly)
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Drug Facts
Active Ingredients (in each tablet)
Acetaminophen USP 325mg.........................................................Pain reliever/fever reducer
Guaifenesin USP 200mg..............................................................Expectorant
Phenylephrine HCL USP 5mg........................................................Decongestant
Dextromethorphan HBr USP 15mg................................................Antitussive
- Purpose
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Uses
Temporarily
- 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 bothersome mucus, drain bronchial tubes, and make coughs more productive
- Suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants
- Temporarily relieves minor aches, pains and fever associated with: headache, common cold, toothache, backache, muscular aches, menstrual cramps
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Warnings: Liver Warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- More than 8 tablets in 24 hours
- With other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure
- 3 or more alcoholic drinks every day while using this product
- Allergy alert:
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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 cold cause serious health concerns.
- use more than the recommended dose
- 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 presription 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
- take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
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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, symptoms do not improve within 7 days or are accompanied by fever, cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition
- Ask a doctor before use if you have:
- Ask a doctor or pharmacist if you are
- Do not exceed recommended dosage
- If pregnant or breast-feeding,
- KEEP OUT OF REACH OF CHILDREN
- Directions:
- WHEN USING
- Other Inforamtion:
- Inactive Ingredients
- Questions or comments?
- COLDTAC Plus2 Tablets in a pouch
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INGREDIENTS AND APPEARANCE
COLDTAC PLUS
acetaminophen, phenylephrin hydrochloride, dextromethorphan hydrobromide tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69517-143 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white Score 2 pieces Shape capsule Size 16mm Flavor Imprint Code A15 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69517-143-06 3 in 1 PACKAGE 10/02/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:69517-143-72 36 in 1 PACKAGE 10/02/2017 2 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/02/2017 Labeler - Healthlife of USA (079656178) Establishment Name Address ID/FEI Business Operations Centurion Laboratories Pvt Ltd 873229784 manufacture(69517-143) , analysis(69517-143) , pack(69517-143)