Label: ACTIVCIN- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
- NDC Code(s): 69729-008-10
- Packager: OPMX LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 5, 2024
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- ACTIVE INGREDIENT
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy alert
Acetaminophen may cause severe skin reactions. Symtoms may include.
Skin reddening blisters • rash • If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning
If sore throat is severe, lasts 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 drug containing acetaminophen (prescription or nonprescription).
- If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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.
Ask a doctor before use if you have
- Liver disease
- Heart disease
- Diabetes
- High blood pressure
- Trouble urinating due to enlarged prostate gland
- Cough that occurs with too much phlegm (mucus)
- Persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema.
Stop use and ask a doctor if
- You get nervouz, dizzy or sleepless.
- Symptoms get worse or last more than 5 days (children) or 7 days (adults).
- Fever gets worse or lasts more than 3 days.
- Redness or swelling is present.
- New symtoms occur.
- Cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL
NDC 69729-008-10
COUGH & FLU / TOS Y GRIPE
Activsin
Day-TimeRelief
Non-Drowsy Multi-Symptom Relief
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
- Body Aches / Dolor de cuerpo
- Fever / Fiebre
- Sore throat / Dolor de cabeza
- Nasal Congestion / Congestion Nasal
- Cough / Tos
10 Softgels / 10 Cápsulas blandas de gel
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INGREDIENTS AND APPEARANCE
ACTIVCIN
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-008 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape OVAL Size 20mm Flavor Imprint Code AP01 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-008-10 1 in 1 CARTON 05/23/2022 1 10 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 05/23/2022 Labeler - OPMX LLC. (029918743) Establishment Name Address ID/FEI Business Operations SOFTECH PHARMA PRIVATE LIMITED 677111277 label(69729-008) , manufacture(69729-008) , pack(69729-008)