DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN- dextromethorphan hydrobromide and guaifenesin syrup 
OPMX LLC

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Histiacil NF Children
Pentrexcilina NF Children
Brosolvan Children

Active Ingredient (in each 5 mL)                      Purpose

Dextromethorphan HBr USP 10 mg............. Cough suppressant

Guaifenesin, USP 100 mg............................... Expectorant

Relieves:
• Chest congestion / Mucus
• Cough

Uses

Warnings

  • Do not useif 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

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feedingask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Age

Dose

Adults and children 12 years and over

2 teaspoonful (10 mL)

Children 6 to under 12 years

1 teaspoonful (5 mL)

Children under 6 years

Ask a doctor

Other information

Inactive ingredients

citric acid, flavor, glycerin, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol.

Questions or comments?
Call 619-600-5632

Tamper evident: Do not use if inner seal under cap is broken or missing.

Exclusively distributed by
OPMX
Chula Vista, CA91910
Phone: 619-600-5632


Manufactured in
FDA Registered Facility
In the USA

PRINCIPAL DISPLAY PANEL

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DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN 
dextromethorphan hydrobromide and guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-035
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-035-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/01/2021
DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN 
dextromethorphan hydrobromide and guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-036
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-036-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/01/2021
DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN 
dextromethorphan hydrobromide and guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-069
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-069-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/01/2021
Labeler - OPMX LLC (029918743)
Establishment
NameAddressID/FEIBusiness Operations
Seaway Pharma Inc.117218785manufacture(69729-035, 69729-036, 69729-069)

Revised: 4/2024
Document Id: 155b9a27-3bf8-5c5d-e063-6294a90a9e30
Set id: 8bb85b23-e9f6-48c7-84b0-15e0e26df4c5
Version: 4
Effective Time: 20240405
 
OPMX LLC