GUAIFENESIN- guaifenesin solution 
American Health Packaging

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Guaifenesin Oral Solution USP
Drug Facts

Expectorant
SUGAR FREE / ALCOHOL FREE

Active ingredient

Purpose

Expectorant

Uses

Warnings

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 if

  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  • you are hypersensitive to any of the ingredients.

If pregnant or breast-feeding,

ask 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

Follow dosage below or use as directed by a physician.

Age (yr)

Dose (ml)

adults and children 12 years and over

10 to 20 ml (2 to 4 teaspoonfuls) every 4 hours

children 6 years to under 12 years

5 to 10 ml (1 to 2 teaspoonfuls) every 4 hours

children 2 years to under 6 years

2.5 to 5 ml (1 /2 to 1 teaspoonful) every 4 hours

children under 2 years

consult a physician

Other Information

  • Each 5 ml contains: sodium 4 mg.
  • Each 10 ml contains: sodium 8 mg.
  • Each 15 ml contains: sodium 12 mg.
  • Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light.
  • DO NOT USE IF SEAL IS BROKEN.
  • Guaifenesin Oral Solution is a red, raspberry flavored solution and is available in the following dosage forms:
    5 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-852-17
    10 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-863-56
    15 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-874-16

Inactive Ingredients

Acesulfame K, citric acid, FD&C Green No. 3, FD&C Red No. 40, flavoring, hydroxyethylcellulose, purified water, sodium benzoate, and sodium citrate.

Questions or comments?

Call 1-800-845-8210

Generic Section

Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Distributed by:
American Health Packaging
Columbus, OH 43217

R0624

Package/Label Principal Display Panel – 100 mg per 5 mL – Label

100 mg per 5 mL Guaifenesin Oral Solution Label

Case NDC 60687- 852-17/Cup NDC 60687- 852-40

Guaifenesin
Oral Solution USP
Expectorant

100 mg per 5 ml

SUGAR FREE / ALCOHOL FREE
Raspberry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]
Protect from light.

FOR INSTITUTIONAL USE ONLY

T0744C050624                 R0624

Package/Label Principal Display Panel – 100 mg per 5 mL – Cup Lid

100 mg per 5 mL Guaifenesin Oral Solution Cup Lid

NDC 60687- 852-40

Guaifenesin
Oral Solution, USP
Expectorant

100 mg per 5 ml

Sugar Free/Alcohol Free
Delivers 5 mL

PROTECT FROM LIGHT.

See package Drug Facts insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0744C050624

Package/Label Principal Display Panel – 200 mg per 10 mL – Label

200 mg per 5 mL Guaifenesin Oral Solution Label

Case NDC 60687- 863-56/Cup NDC 60687- 863-42

Guaifenesin
Oral Solution USP
Expectorant

200 mg per 10 ml

Sodium Content: 8 mg/10 ml
SUGAR FREE / ALCOHOL FREE
Raspberry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]
Protect from light.

FOR INSTITUTIONAL USE ONLY

T0744C100624                 R0624

Package/Label Principal Display Panel – 200 mg per 10 mL – Cup Lid

200 mg per 5 mL Guaifenesin Oral Solution Cup Lid

NDC 60687- 863-42

Guaifenesin
Oral Solution, USP
Expectorant

200 mg per 10 ml

Sodium Content: 8 mg/10 ml
Sugar Free/Alcohol Free
Delivers 10 mL

PROTECT FROM LIGHT.

See package Drug Facts insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0744C100624

Package/Label Principal Display Panel – 300 mg per 15 mL – Label

300 mg per 5 mL Guaifenesin Oral Solution Label

Case NDC 60687- 874-16/Cup NDC 60687- 874-44

Guaifenesin
Oral Solution USP
Expectorant

300 mg per 15 ml

Sodium Content: 12 mg/15 ml
SUGAR FREE / ALCOHOL FREE
Raspberry Flavor

Usual Dosage: See attached Drug Facts.

Store at 20° to 25°C (68° to 77°F) [See USP]
Protect from light.

FOR INSTITUTIONAL USE ONLY

T0744C150624                 R0624

Package/Label Principal Display Panel – 300 mg per 15 mL – Cup Lid

300 mg per 5 mL Guaifenesin Oral Solution Cup Lid

NDC 60687- 874-44

Guaifenesin
Oral Solution, USP
Expectorant

300 mg per 15 ml

Sodium Content: 12 mg/15 ml
Sugar Free/Alcohol Free
Delivers 15 mL

PROTECT FROM LIGHT.

See package Drug Facts insert for full
prescribing information and storage.

For Institutional Use Only.

American Health Packaging
Columbus, OH 43217

F0744C150624

GUAIFENESIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-852
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60687-852-1710 in 1 CASE10/20/2024
1NDC:60687-852-4610 in 1 TRAY
1NDC:60687-852-405 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/20/2024
GUAIFENESIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-863
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60687-863-5610 in 1 CASE10/20/2024
1NDC:60687-863-4810 in 1 TRAY
1NDC:60687-863-4210 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/20/2024
GUAIFENESIN 
guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-874
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN300 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60687-874-1610 in 1 CASE10/20/2024
1NDC:60687-874-5010 in 1 TRAY
1NDC:60687-874-4415 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/20/2024
Labeler - American Health Packaging (929561009)

Revised: 10/2024
Document Id: 24b1b6f4-c113-8adc-e063-6394a90a546c
Set id: 2fd702ea-3069-472c-b99e-c527f1375705
Version: 1
Effective Time: 20241017
 
American Health Packaging