AMPIGRIN ULTRA FORTE NIGHT- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled 
OPMX LLC

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Ampigrin Ultra Forte - Night

Drug Facts

Active ingredients (in each Softgels)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine

Uses

Temporarily relieves common cold/flu symptoms:

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 away

Sore 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

Stop use and ask a doctor if

  • Pain or cough 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
  • Cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

Adults & children 12 yrs & over2 softgels with water every 6 hrs
Children 4 to under 12 yrsAsk a doctor
Children under 4 yrsDo not use

Other information

Inactive ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide

Questions?

Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST

Made for:

RRX



Exclusively distributed by:

OPMX

Chula Vista, CA 91910

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

10 Softgels

Ampigrin_Ultra_Forte

AMPIGRIN ULTRA FORTE NIGHT 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorgreenScoreno score
ShapeOVALSize20mm
FlavorImprint Code AP02
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-003-1010 in 1 CARTON06/10/2022
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/10/2022
Labeler - OPMX LLC (029918743)
Establishment
NameAddressID/FEIBusiness Operations
SOFTECH PHARMA PRIVATE LIMITED677111277label(69729-003) , manufacture(69729-003) , pack(69729-003)

Revised: 4/2024
Document Id: 155eb181-15ee-4d72-e063-6294a90a9392
Set id: e11e71c3-fe7c-77c7-e053-2995a90a34b2
Version: 2
Effective Time: 20240405
 
OPMX LLC