GILTUSS DIABETIC COUGH AND COLD- dextromethorphan hydrobromide, guaifenesin solution

Giltuss Diabetic by

Drug Labeling and Warnings

Giltuss Diabetic by is a Otc medication manufactured, distributed, or labeled by Gil Pharmaceutical Corp, Dextrum Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 10 mL)

Dextromethorphan HBr, 20 mg

Guaifenesin 200 mg

PURPOSE

Purposes

Cough Suppressant

Expectorant

INDICATIONS & USAGE

Uses

• temporarily relieves
• cough due to minor throat and bronchial irritation associated with a common cold or inhaled irritants
• the intensity of coughing
• the impulse to cough to help you get to sleep
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive and drain bronchial tubes

Warnings

Do not use

• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOl drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

When using this product do not use more than directed

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

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or is accompanied by fever, rash or headache that lasts as these could be signs of a serious condition.

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

Keep out of reach of children. In case of accidental overdose, get medical or professional help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• do not take more than 6 doses in any 24-hour period
• keep dosing cup with product
• mL = milliliters

• Adults and children 12 years and over: 10 mL every 4 hours
• children 6 to under 12 years of age: 5 mL every 4 hours
• children 2 to under 6 years of age: 2.5 mL every 4 hours
• children under 2 years of age: Do not use

STORAGE AND HANDLING

Other information

• store at room temperature, between 15°- 30°C (59°- 86°F)
• close cap tightly
• SAVE CARTON FOR COMPLETE DRUG FACTS

INACTIVE INGREDIENT

Inactive ingredients: Citric acid, flavor, menthol, methylparaben, propylene glycol, propylparaben, purified water and sucralose.

QUESTIONS

Questions or comments?

Call 1-787-848-9114, Monday-Friday 9AM-5PM EST.

Call your doctor for medical advice in the event of side effects.

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MANUFACTURED FOR

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

OTHER SAFETY INFORMATION

Tamper evident: do not use if safety seal is broken or missing.

PERSONS WITH DIABETES: CONSULT YOUR DOCTOR OR PHARMACIST BEFORE USING ANY MEDICATION OR DIETARY SUPPLEMENT

THIS PRODUCT DOES NOT CONTAIN ANY MEDICATION TO IMPROVE OR RELIEVE DIABETES

PRINCIPAL DISPLAY PANEL

Giltuss® DIABETIC

COUGH & COLD

RELIEVES

• COUGH AND COLD
• CHEST CONGESTION
• LIQUIFIES AND LOOSENS PHLEGM AND MUCUS

SAFE FOR PEOPLE WITH DIABETES

GRAPE FLAVOR

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

GILTUSS DIABETIC  COUGH AND COLD
dextromethorphan hydrobromide, guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58552-134
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
METHYLPARABEN (UNII: A2I8C7HI9T)
MENTHOL (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58552-134-04	1 in 1 CARTON	10/17/2018
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/17/2018

Labeler - Gil Pharmaceutical Corp (176826592)

Establishment
Name	Address	ID/FEI	Business Operations
Dextrum Laboratories Inc.		007392322	manufacture(58552-134)