Guaifenesin And Codeine Phosphate

Guaifenesin And Codeine Phosphate
SPL v11
SPL
SPL Set ID 88d0994c-4270-4408-8837-bd97510b2118
Route
ORAL
Published
Effective Date 2023-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (100 mg) Codeine Anhydrous (10 mg)
Inactive Ingredients
Sodium Citrate Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Glycerin Menthol, Unspecified Form Propylene Glycol Water Sodium Benzoate Anhydrous Citric Acid Saccharin Sodium Sorbitol

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2006-10-01 Until 2023-08-02
Description

Drug Facts

Medication Information

Description

Drug Facts

Uses
  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Use of codeine-containing preparation is not recommended for children under 2 years of age.
Section 50568-5

Ask a doctor or pharmacist before use if you aretaking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1
Active ingredients in each 5 mL (teaspoonful) Purposes
Codeine Phosphate, USP 10 mg Cough Suppressant
Guaifenesin, USP 100 mg Expectorant
Directions
  • take every 4 hours
  • do not exceed 6 doses in 24 hours
  • a special measuring device should be used to give an accurate dose of this product to children under 6 years of age
  • giving a higher dose than recommended by a doctor can result in serious side effects for a child
adults and children 12 years and over 10 mL (2 teaspoonfuls)
children 6 to under 12 years of age 5 mL (1 teaspoonful)
children under 6 years of age Consult a doctor
Do Not Use
  • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.
Other Information
  • Sodium Content:5 mg/5 mL
  • Tamper evident: Do not use if seal under cap is broken or missing
  • Keep container closed and store away from heat
  • Store at 20°- 25°C (68°-77°F)
Inactive Ingredients

Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

Questions Or Comments?

Call 1-800-845-8210 or visit paipharma.com

Serious side effects associated with use of this product may be reported to this number.

Stop Use and Ask A Doctor If
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.
  • may cause or aggravate constipation
Ask A Doctor Before Use If You Have
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Principal Display Panel 473 Ml Bottle Label

NDC 0121-0775-16

Guaifenesin and Codeine

Phosphate Oral Solution USP

CV

100 mg/10 mg per 5 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Each teaspoonful (5 mL) contains:

Guaifenesin, USP 100 mg

Codeine Phosphate, USP 10 mg

Dispense in a tight, light-resistant

container with a child-resistant closure.

DO NOT ACCEPT IF SEAL

AROUND CAP IS BROKEN OR MISSING

16 fl oz (473 mL)

pai

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

Principal Display Panel 5 Ml Unit Dose Cup Label

Delivers 5 mL

NDC 0121-1775-05

G UAIFENESINAND C ODEINEP HOSPHATE 

O RALS OLUTIONUSP CV

100 mg/10 mg per 5 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Principal Display Panel 10 Ml Unit Dose Cup Label 

Delivers 10 mL

NDC 0121-1550-10

G UAIFENESINAND C ODEINE P HOSPHATE

O RALS OLUTIONUSP CV

200 mg/20 mg per 10 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Use of codeine-containing preparation is not recommended for children under 2 years of age.
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients in each 5 mL (teaspoonful) Purposes
Codeine Phosphate, USP 10 mg Cough Suppressant
Guaifenesin, USP 100 mg Expectorant
Directions
  • take every 4 hours
  • do not exceed 6 doses in 24 hours
  • a special measuring device should be used to give an accurate dose of this product to children under 6 years of age
  • giving a higher dose than recommended by a doctor can result in serious side effects for a child
adults and children 12 years and over 10 mL (2 teaspoonfuls)
children 6 to under 12 years of age 5 mL (1 teaspoonful)
children under 6 years of age Consult a doctor
Do Not Use (Do not use)
  • in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.
Other Information (Other information)
  • Sodium Content:5 mg/5 mL
  • Tamper evident: Do not use if seal under cap is broken or missing
  • Keep container closed and store away from heat
  • Store at 20°- 25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.

Questions Or Comments? (Questions or comments?)

Call 1-800-845-8210 or visit paipharma.com

Serious side effects associated with use of this product may be reported to this number.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.
  • may cause or aggravate constipation
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

NDC 0121-0775-16

Guaifenesin and Codeine

Phosphate Oral Solution USP

CV

100 mg/10 mg per 5 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Each teaspoonful (5 mL) contains:

Guaifenesin, USP 100 mg

Codeine Phosphate, USP 10 mg

Dispense in a tight, light-resistant

container with a child-resistant closure.

DO NOT ACCEPT IF SEAL

AROUND CAP IS BROKEN OR MISSING

16 fl oz (473 mL)

pai

Pharmaceutical

Associates, Inc.

Greenville, SC 29605

Principal Display Panel 5 Ml Unit Dose Cup Label (PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label)

Delivers 5 mL

NDC 0121-1775-05

G UAIFENESINAND C ODEINEP HOSPHATE 

O RALS OLUTIONUSP CV

100 mg/10 mg per 5 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Principal Display Panel 10 Ml Unit Dose Cup Label  (PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label )

Delivers 10 mL

NDC 0121-1550-10

G UAIFENESINAND C ODEINE P HOSPHATE

O RALS OLUTIONUSP CV

200 mg/20 mg per 10 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:33.015980 · Updated: 2026-03-14T23:03:40.356549