Label: COLD MULTI-SYMPTOM DAY-TIME- acetaminophen,guaifenesin, dextromethorphan hbr and phenylephrine hci tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 69168-323-86 - Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
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 December 23, 2014
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets 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
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do Not Use
with any other products containing acetaminophen (prescription or nonprescription). If you are not
sure whether a drug contains acetaminophen, ask a doctor or pharmacistif 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 the MAOI drugs. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this productAsk a doctor before use if you have
liver disease■ heart disease■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating
due to an enlarged prostate gland ■ cough that occurs with too much phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysemaAsk a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin taking sedatives or tranquilizers
Stop use and ask a doctor if
■ nervousness, dizziness, or sleeplessness occur ■ pain, nasal congestion or cough gets worse or lasts for more than 7 days ■ fever gets worse or lasts for more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
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INGREDIENTS AND APPEARANCE
COLD MULTI-SYMPTOM DAY-TIME
acetaminophen,guaifenesin, dextromethorphan hbr and phenylephrine hci tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-323 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSES (UNII: 3NXW29V3WO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONES (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSPOVIDONE (UNII: 68401960MK) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) Product Characteristics Color YELLOW Score no score Shape OVAL Size 19mm Flavor Imprint Code AZ323 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-323-86 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 12/23/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/23/2014 Labeler - Allegiant Health (079501930) Registrant - Allegiant Health (079501930) Establishment Name Address ID/FEI Business Operations Allegiant Health 079501930 ANALYSIS(69168-323) , LABEL(69168-323) , MANUFACTURE(69168-323) , PACK(69168-323) , RELABEL(69168-323) , REPACK(69168-323)