Label: AMPIGRIN ULTRA FORTE NIGHT- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
- NDC Code(s): 69729-003-10
- Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 5, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
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. Symptoms may include:
• skin reddening • blisters • rash • If a skin reaction occurs, stop use and seek medical help right awaySore throat warning
If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
When using this product
- Excitability may occur, especially in children
- Marked drowsiness may occur
- Avoid Alcoholic drinks
- Be careful when driving a motor vehicle or operating machinery
- Alcohol, sedatives, & tranquilizers may increase drowsiness
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
NDC 69729-003-10
Ampigrin Ultra Forte
Acetaminophen 325 mg Pain Reliever/Fever Reducer
Dextromethorphan HBr 15 mg, Cough suppressant
Doxylamine Succinate 6.25 mg Antihistamine
COLD & COUGH
- Cough Suppressant
- Expectorant
- Nasal Congestion
- Sneezing
- Itchy, Watery Eyes & Runny Nose
- Descongestionante de las vías Respiratorias
- Congestión Nasal
- Estornudos
- Comezon, Ojos llorosos y Escurrimiento Nasal
10 Softgels
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INGREDIENTS AND APPEARANCE
AMPIGRIN ULTRA FORTE NIGHT
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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 green Score no score Shape OVAL Size 20mm Flavor Imprint Code AP02 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-003-10 10 in 1 CARTON 06/10/2022 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 06/10/2022 Labeler - OPMX LLC (029918743) Establishment Name Address ID/FEI Business Operations SOFTECH PHARMA PRIVATE LIMITED 677111277 label(69729-003) , manufacture(69729-003) , pack(69729-003)