Maximum Strength-cough And Chest Congestion Dm Liquid Filled Capsules

Maximum Strength-cough And Chest Congestion Dm Liquid Filled Capsules
SPL v3
SPL
SPL Set ID d1830989-fe82-4f08-8618-78979fcef568
Route
ORAL
Published
Effective Date 2019-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (200 mg)
Inactive Ingredients
Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Sorbitol Water

Identifiers & Packaging

Pill Appearance
Imprint: PC37 Shape: capsule Color: red Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-06-30

Description

Drug Facts

Purpose

Cough suppressant Expectorant


Medication Information

Purpose

Cough suppressant

Expectorant

Description

Drug Facts

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50569-3

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)

• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Section 53414-9

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

Directions

• do not take more than 12 softgels in any 24-hour period

• this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

2 softgels every 4 hours

children under 12 years

do not use

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

Other Information

• store at room temperature 15-30°C (59-86°F)

• avoid excessive heat above 40°C (104°F)

Inactive Ingredients

FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Wuhan, Hubei

430206, China

Stop Use and Ask A Doctor If

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Active Ingredient (in Each Softgel)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

Principal Display Panel Shipping Label

Maximum Strength-Cough and Chest Congestion DM Liquid Filled Capsules

Quantity : 4000 Capsules

NDC. No : 53345-034-01

IMPORTANT:

Inspect immediately upon receipt.

This is a bulk shipment, intended for further processing only.

Protect from heat, humidity, and light. Do not refrigerate.

Store at 15-30°C (59-86°F)

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING


Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

• cough that occurs with too much phlegm (mucus)

• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Section 53414-9 (53414-9)

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

Purpose

Cough suppressant

Expectorant

Directions

• do not take more than 12 softgels in any 24-hour period

• this adult product is not intended for use in children under 12 years of age

age

dose

adults and children 12 years and over

2 softgels every 4 hours

children under 12 years

do not use

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

Other Information (Other information)

• store at room temperature 15-30°C (59-86°F)

• avoid excessive heat above 40°C (104°F)

Inactive Ingredients (Inactive ingredients)

FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.

Wuhan, Hubei

430206, China

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 200 mg

Principal Display Panel Shipping Label (PRINCIPAL DISPLAY PANEL - Shipping Label)

Maximum Strength-Cough and Chest Congestion DM Liquid Filled Capsules

Quantity : 4000 Capsules

NDC. No : 53345-034-01

IMPORTANT:

Inspect immediately upon receipt.

This is a bulk shipment, intended for further processing only.

Protect from heat, humidity, and light. Do not refrigerate.

Store at 15-30°C (59-86°F)

CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING


Advanced Ingredient Data


Raw Label Data

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