OTC Medication Information: L-Oral COLD AND FLU RELIEF-DS Syrup

L-ORAL COLD AND FLU RELIEF-DS SYRUP- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate 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 INGREDIENTS (IN EACH 30 ML)

Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg

PURPOSE

Pain reliever / Fever reducer
Cough suppressant
Antihistamine

USES

Temporarily relieves common cold/flu symptoms: Cough due to minor throat and bronchial irritation Sore throat Headache Minor aches and pains Fever Runny nose and sneezing

WARNINGS

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

More than 4,000 mg of acetaminophen in 24 hours With other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening Blisters Rash
If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

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

If you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have • Liver disease Glaucoma Cough that occurs with too much phlegm (mucus) A breathing problem such as emphysema or chronic bronchitis Trouble urinating due to an enlarged prostate gland Persistent or chronic cough as occurs with smoking, asthma, or emphysema A sodium-restricted diet

Ask a doctor or pharmacist before use if you are • Taking sedatives or tranquilizers Taking the blood thinning drug

When using this product
Excitability may occur, especially in children Marked drowsiness may occur Avoid alcoholic drinks Be careful when driving a motor vehicle or operating machinery Alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if • Pain or cough gets worse or lasts more than 7 days Fever gets worse or lasts more than 3 days Redness or swelling is present New symptoms occur Cough comes back or occurs with 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as or children even if you do not notice any signs or symptoms.

DIRECTIONS

Take only as directed — see Overdose warning Use dose cup Do not exceed 4 doses per 24 hrs

Adults & children 12 yrs & over 30 mL every 6 hrs
Children 4 to under 12 yrs Ask a doctor
Children under 4 yrs Do not use

OTHER INFORMATION

Each 30 mL contains: sodium 38 mg Store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

Alcohol, Anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, Flavor, High fructose corn syrup, Polyethylene glycol, Propylene glycol, Purified water, Saccharin sodium, Sodium citrate

QUESTIONS OR COMMENTS?

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

√ Cough Relief √ Aches
√ Fever √ Sore throat
√ Sneezing/Runny nose
Manufactured by:

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 — INDIA.

www.global-pharma.com

Packaging

coldflu028
(click image for full-size original)

L-ORAL COLD AND FLU RELIEF-DS SYRUP
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73921-028
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C GREEN NO. 3
FD&C YELLOW NO. 6
HIGH FRUCTOSE CORN SYRUP
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM CITRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73921-028-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 118 mL in 1 BOTTLE This package is contained within the CARTON (73921-028-30)
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 (73921-028)

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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