FDA.reportPublic FDA data

Guaifenesin and Codeine Phosphate

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2021-02-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:53:22

Label at a glance#

ProductGuaifenesin and Codeine Phosphate
Active ingredientGUAIFENESIN, CODEINE PHOSPHATE
Label structure9 sections

Indications and 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

Dosage and administration

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 Con...

Storage and handling

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)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

  • 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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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 SECTION

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

OTC - STOP USE SECTION

  • 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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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 INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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 -

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-1350-42024-08-02C16284748780-1ba0f9c33-25ab-a910-e053-dadaa90a0b85Guaifenesin and Codeine Phosphate
68071-1350-42023-01-30C16284748780-1ba0f9c33-25ab-a910-e053-dadaa90a0b85Guaifenesin and Codeine Phosphate
68071-1350-42021-02-10C16284748780-1ba0f9c33-25ab-a910-e053-dadaa90a0b85Guaifenesin and Codeine Phosphate
68071-1350-42021-01-29C16284748780-1ba0f9c33-25ab-a910-e053-dadaa90a0b85Guaifenesin and Codeine Phosphate

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68071-1350-4ML - Milliliter68071-13508a0650cc-3945-4116-af91-f08271a8dd1712018-08-13
0121-0775-04ML - Milliliter0121-0775ac9f8c15-4f02-4667-b975-5c20f7d93dab12012-07-24
0121-0775-08ML - Milliliter0121-0775ef3933a2-ccb0-4b44-977e-b6b8f9f14e1212018-02-20
0121-0775-16ML - Milliliter0121-0775270b5b4b-ceb0-4155-ad98-6b3454cf2a2912012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-135068071-1350-4
0121-0775

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
GUAIFENESIN495W7451VQACTIB
CODEINE PHOSPHATEGSL05Y1MN6ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEPAI Holdings, LLC88d0994c-4270-4408-8837-bd97510b21182024-09-06WarningsExact identifier
ndc (product): 0121-0775
19c4a9b9-a3b5-1026-e063-6394a90ac82570598f87-991a-e367-e053-2a91aa0acc2f2024-05-31WarningsExact identifier
spl set id: 70598f87-991a-e367-e053-2a91aa0acc2f