OTC Medication Information: L-Oral COUGH RELIEF Syrup

L-ORAL COUGH RELIEF SYRUP- dextromethorphan hydrobromide and 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.

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
(click image for full-size original)

L-ORAL COUGH RELIEF SYRUP
dextromethorphan hydrobromide, guaifenesin syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73921-029
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM
CHERRY
VANILLA BEAN
ASPARTAME
HYPROMELLOSE, UNSPECIFIED
MENTHOL, UNSPECIFIED FORM
METHYLPARABEN
POTASSIUM SORBATE
WATER
CITRIC ACID MONOHYDRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73921-029-04 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (73921-029-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 04/01/2021
Labeler — GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)
Establishment
Name Address ID/FEI Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED 860186917 manufacture (73921-029)

Revised: 03/2021 GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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