Label: COLD MEDICINE tablet
- NDC Code(s): 69168-004-51
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 23, 2021
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- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 10 tablets 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 right away.
Do not use
- if you are allergic to acetaminophen
- more than 10 days unless directed by a doctor
- 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 drug.
If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this
product
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not
sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
you have
- liver disease
- heart disease
- glaucoma
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if
- are taking the blood thinning drug warfarin
- are taking sedatives or tranquilizers
When using this product
- do not use more than directed
- excitability may occur, especially in children
- may cause
- drowsiness
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- redness or swelling is present
- new symptoms occur
- you get nervous, dizzy, or sleepless
- pain or nasal congestion gets worse or lasts for more than 7 days
- fever gets worse or lasts for more than 3 days
Keep out of reach of children
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical
help or contact a Poison Control Center right away. 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 use more than directed
-
Adults and children 12 years of age and older: take 2 tablets every 4 to 6 hours
Do not take more than 10 tablets in 24 hours
-
Children under 12 years of age: do not use this product in children under 12 years
of age; this will provide more than the recommended dose (overdose) and may cause
liver damage.
- Other information
- Inactive ingredients
- Questions
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
COLD MEDICINE
cold medicine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-004 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code AZ275 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-004-51 20 in 1 CARTON; Type 0: Not a Combination Product 11/23/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 11/12/2021 Labeler - Allegiant Health (079501930)
