Label: ANTIGRIP COUGH AND COLD- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hci0 capsule, gelatin coated
- NDC Code(s): 55758-043-08
- Packager: Pharmadel LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 26, 2024
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Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 gelcaps in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Do not use
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product
Ask a doctor before use if you
- have liver disease
- have heart disease
- have high blood pressure
- have thyroid disease
- have diabetes
- have glaucoma
- have a breathing problem such as emphysema or chronic bronchitis
- have difficulty in urination due to enlargement of the prostate gland
- have a persistent or chronic cough as occurs with smoking, asthma, or emphysema
- have a cough that is accompanied by excessive phlegm (mucus)
- are taking sedatives or tranquilizers
When using this product
- do not exceed the recommended dosage
- may cause marked drowsiness
- may cause excitability, especially in children
- avoid alcoholic beverages while taking this product
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor If
- nervousness, dizziness, or sleeplessness occurs
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- a cough comes back or occurs with a rash headache that lasts. These could be signs of a serious condition.
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INGREDIENTS AND APPEARANCE
ANTIGRIP COUGH AND COLD
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hci0 capsule, gelatin coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-043 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE (UNII: 1WS297W6MV) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color blue Score score with uneven pieces Shape CAPSULE (Oblong Soft gel capsule) Size 21mm Flavor Imprint Code SN5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-043-08 1 in 1 BOX 03/24/2024 1 8 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 M012 03/24/2024 Labeler - Pharmadel LLC (030129680)