Guaifenesin And Codeine Phosphate Solution
FDA Label NDC 0121-0775

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc for the product Guaifenesin And Codeine Phosphate (NDC 0121-0775). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients in each 5 mL (teaspoonful)Purposes
Codeine Phosphate, USP 10 mgCough Suppressant
Guaifenesin, USP 100 mgExpectorant

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

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.

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking 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.

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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.

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 over10 mL (2 teaspoonfuls)
    children 6 to under 12 years of age5 mL (1 teaspoonful)
    children under 6 years of ageConsult 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.

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 (473 mL Bottle Label)

Principal Display Panel (473 mL Bottle Label)

Principal Display Panel - 10 Ml Unit Dose Cup Label

Delivers 10 mL

NDC 0121-1550-10

G UAIFENESIN AND

C ODEINE P HOSPHATE

O RAL S OLUTION USP

CV

200 mg/20 mg per 10 mL

Expectorant / Cough Suppressant

Alcohol Free / Sugar Free

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

A17751001

Principal Display Panel (10 mL Unit Dose Cup Label)

Principal Display Panel (10 mL Unit Dose Cup Label)

Principal Display Panel - 10 Ml Unit Dose Cup Label - 1775

Delivers 10 mL

NDC 0121-1775-10

G UAIFENESIN AND
C ODEINE P HOSPHATE
O RAL S OLUTION USP
CV

200 mg/20 mg per 10 mL

Expectorant / Cough Suppressant
Alcohol Free / Sugar Free

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT

A17751000

Principal Display Panel (10 mL Unit Dose Cup Label)

Principal Display Panel (10 mL Unit Dose Cup Label)

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