Cheratussin AC

Manufacturer
REMEDYREPACK INC.
Effective date
2019-02-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:31:51

Label at a glance#

ProductCheratussin AC
Active ingredientCODEINE PHOSPHATE, GUAIFENESIN
Label structure14 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive calms the cough control center and relieves coughing

Dosage and administration

take every 4 hours do not take more than 6 doses in any 24-hour period adults and children 12 years and over take 10 mL (2 tsp) children 6 years to under 12 years take 5 mL (1 tsp) children 2 years to under 6 years consult a doctor children under 2 years do not use Attention: 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 th...

Storage and handling

store at 15° to 30°C (59° to 86°F) You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811 .

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL = 1 tsp)

OTC - ACTIVE INGREDIENT SECTION

Codeine phosphate, USP 10 mg

Guaifenesin, USP 100 mg

Purpose

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • calms the cough control center and relieves coughing

OTC - DO NOT USE SECTION

Do not use

  • in a child under 2 years of age
  • if you or your child has a chronic pulmonary disease or shortness of breath
  • if your child is taking other drugs, unless directed by a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - WHEN USING SECTION

When using this product constipation may occur or be aggravated

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 hours
  • do not take more than 6 doses in any 24-hour period

adults and children 12 years and over

take 10 mL (2 tsp)

children 6 years to under 12 years

take 5 mL (1 tsp)

children 2 years to under 6 years

consult a doctor

children under 2 years

do not use

Attention: 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 could result in serious side effects for your child.

Other information

STORAGE AND HANDLING SECTION

store at 15° to 30°C (59° to 86°F)

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol, caramel, citric acid, FD&C red #40, flavor, glycerin, menthol racemic, purified water, saccharin sodium, sodium benzoate, sorbitol solution

SPL UNCLASSIFIED SECTION

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 1/15 R7 8081202 1075

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Cheratussin AC

GENERIC: codeine phosphate and guaifenesin

DOSAGE: LIQUID

ADMINSTRATION: ORAL

NDC: 70518-1843-0

COLOR: red

FLAVOR: CHERRY

PACKAGING: 118 mL in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • CODEINE PHOSPHATE 10mg in 5mL
  • GUAIFENESIN 100mg in 5mL

INACTIVE INGREDIENT(S):

  • ALCOHOL
  • WATER
  • MENTHOL
  • SACCHARIN SODIUM
  • SODIUM BENZOATE
  • ANHYDROUS CITRIC ACID
  • CARAMEL
  • GLYCERIN
  • FD&C RED NO. 40
  • SORBITOL

Remedy_LabelRemedy_Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-1075-54ML - Milliliter0603-1075c60a8c2e-2409-4881-84bf-5ea7a871513e12012-07-24
0603-1075-56ML - Milliliter0603-107538955374-289d-4a63-b987-af3b0941c04412012-07-24
0603-1075-58ML - Milliliter0603-1075cdb653c5-5c9e-4827-8d8b-f82b44b8371f12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-184370518-1843-0
0603-1075

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a8387c28-5383-ae70-e053-2a95a90addb7a807d877-fab2-41ed-bc21-486a1a0470b22020-06-16WarningsExact identifier
spl set id: a807d877-fab2-41ed-bc21-486a1a0470b2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.