Label: COLD MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, coated
- NDC Code(s): 69168-324-86
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 2, 2019
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- Active ingredient(s)
- Purpose
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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
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
■ skin reddening
■ blisters
■ rash
If a skin reaction occurs, stop use and seek medical help immediately
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 pharmacist n 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 the MAOI drugs. If you do not know if your prescription drugs contains an MAOI, ask a doctor or pharmacist.
Ask a doctor before use if you have
■ liver disease
■ heart disease n high blood pressure
■ thyroid disease
■ diabetes
■ trouble urinating due to an enlarged prostate gland
■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema n cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
Stop use and ask a doctor if
■ nervousness, dizziness or sleeplessness occurs
■ pain gets worse or lasts more than 7 days n fever gets worse or lasts more than 3 days
■ redness or swelling is present n new symptoms occur
■ cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
Keep out of reach of children
Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for
children even if you do not notice any signs or symptoms.
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Directions
do not take more than directed (see Warnings)
Adults and children 12 years and over:
■ take 2 caplets every 4 hours
■ do not take more than 12 caplets in 24 hours
Children under 12 years: do not use this adult product in children under 12 years of age.
This will provide more than the recommended dose (overdose) and may cause liver damage
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INGREDIENTS AND APPEARANCE
COLD MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-324 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 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) CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape CAPSULE Size 17mm Flavor Imprint Code AZ;324 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-324-86 1 in 1 CARTON 08/15/2015 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 08/15/2015 Labeler - Allegiant Health (079501930)
