L-Oral COUGH RELIEF SYRUP

L-Oral COUGH RELIEF Syrup by

Drug Labeling and Warnings

L-Oral COUGH RELIEF Syrup by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

L-ORAL COUGH RELIEF SYRUP- dextromethorphan hydrobromide, guaifenesin syrup 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

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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L-Oral COUGH RELIEF SYRUP

DRUG FACTS

ACTIVE INGREDIENT

Each 5 mL (1 teaspoonful) contains:
Dextromethorphan HBr  
Guaifenesin  

PURPOSE

Cough Suppressant
Expectorant

INACTIVE INGREDIENTS

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

USES

Temporarily relieves cough

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

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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
A cough that occur with too much phlegm (mucus)
A chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if
A 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,
ask a health professional before use.

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

Professional note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

DIRECTIONS

Take every 4 hours
Do not exceed 6 doses in 24 hours

 Age Dose
 Adults & children 12 years & over 10 mL (2 teaspoonfuls)
 Children 6 years to under 12 years 5 mL (1 teaspoonful)
 Children 2 years to under 6 years 2.5 mL (1/2 teaspoonful)
 Children under 2 years Ask a doctor

How Supplied: Dextromethorphan HBr and Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

Storage:

Keep tightly closed. Store at controlled room temperature 20-25° C (68-77°F). [See USP] Protect from light.

QUESTIONS OR COMMENTS?

Call toll-free 1-800-572-6632, weekdays, 7:00 AM - 5:30 PM EST.

Expectorant & Cough Relief

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

Loral29-2

L-ORAL COUGH RELIEF SYRUP 
dextromethorphan hydrobromide, guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73921-029
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CHERRY (UNII: BUC5I9595W)  
VANILLA BEAN (UNII: Q74T35078H)  
ASPARTAME (UNII: Z0H242BBR1)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73921-029-041 in 1 CARTON04/01/202102/08/2023
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/202102/08/2023
Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)
Establishment
NameAddressID/FEIBusiness Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED860186917manufacture(73921-029)

Revised: 2/2023
 

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