FDA.reportPublic FDA data

Diabetic Tussin Expectorant

Manufacturer
REMEDYREPACK INC.
Effective date
2022-07-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:56:47

Label at a glance#

ProductDiabetic Tussin Expectorant
Active ingredientGUAIFENESIN
Label structure10 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

Dosage and administration

take every 4 hours do not exceed 6 doses in 24 hours Adults 10 mL - 20 mL (2 - 4 teaspoons) Children under 12 years ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DIABETIC TUSSIN EXPECTORANT- guaifenesin liquid 
Medtech Products Inc., a Prestige Consumer Healthcare company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

Warnings

WARNINGS SECTION

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • a cough that occurs with too much phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts

These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 exceed 6 doses in 24 hours
Adults10 mL - 20 mL (2 - 4 teaspoons)
Children under 12 yearsask a doctor

Other information

OTHER SAFETY INFORMATION

  • Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
  • store at room temperature 20-25°C (68-77°F).
  • keep tightly closed.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame K, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Diabetic Tussin Expectorant

GENERIC: Guaifenesin

DOSAGE: LIQUID

ADMINSTRATION: ORAL

NDC: 70518-3445-0

NDC: 70518-3445-1

FLAVOR: CHERRY

PACKAGING: 20 mL in 1 CUP, UNIT-DOSE

OUTER PACKAGING: 10 in 1 BOX

ACTIVE INGREDIENT(S):

  • GUAIFENESIN 200mg in 10mL

INACTIVE INGREDIENT(S):

  • ACESULFAME POTASSIUM
  • ASPARTAME
  • CHERRY
  • HYPROMELLOSE, UNSPECIFIED
  • MENTHOL, UNSPECIFIED FORM
  • METHYLPARABEN
  • POTASSIUM SORBATE
  • VANILLA
  • WATER
  • ANHYDROUS CITRIC ACID

Remedy_LabelRemedy_Label

MM2MM2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61787-514-04ML - Milliliter61787-514d4538812-5eee-4755-9381-e3a0ed7f105712021-03-02

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-344570518-3445-1, 70518-3445-0
61787-514

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACESULFAME POTASSIUM23OV73Q5G9IACT
ASPARTAMEZ0H242BBR1IACT
CHERRYBUC5I9595WIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
VANILLAQ74T35078HIACT
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GUAIFENESIN495W7451VQACTIB

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
fb453b29-ffe2-bc31-e053-6394a90ab7f938b56b47-141f-4134-8a91-bdb5376adf5f2023-05-09WarningsExact identifier
spl set id: 38b56b47-141f-4134-8a91-bdb5376adf5f

Reported adverse events (FAERS/openFDA)#

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