Exchange Select Chest Congestion & Cough Relief Dm

Exchange Select Chest Congestion & Cough Relief Dm
SPL v2
SPL
SPL Set ID 89494a7c-cdbf-48f1-aaa9-2e57d4388a68
Route
ORAL
Published
Effective Date 2025-01-07
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 Water Sorbitol Sorbitan Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Drug Facts Active ingredients (per softgel) Dextromethorphan HBr 10 mg Guaifenesin 200 mg


Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses

■ helps loosen phlegm (mucus) and thin broochial secretions to make cough more

   productlve

■ temporarily relieves cough due to minor throat and bronchial irritation as may

  occur with a cold

Dosage and Administration

Directions

■ Do not take more than 12 softgels in any 24·hour period

■ This product is nol lntended for use in children under 12 years

■ Adults & children 12 years and over - 2 softgels every 4 hours

■ Children under 12 years of age - do not use

Description

Drug Facts Active ingredients (per softgel) Dextromethorphan HBr 10 mg Guaifenesin 200 mg

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 50566-9

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is

accompanied by fever, rash, or persistent headache. These could be signs of a

serious condition.

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 51727-6

Inactive ingredients

FD&C Red # 40, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene

glycol, Purified water, Sorbitol sorbllan solulion, Titanium dioxide

Section 53413-1

Questions? 1-877-798-5944

Section 53414-9

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

Section 55105-1

Purposes

Dextromethorphan HBr ..........................Cough Suppressant

Guaifenesin       ....................................Expectorant

Section 55106-9

Drug Facts



Active ingredients (per softgel)

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Section 60561-8

Other information

■ Store at room temperature

■ Avoid excessive heat above 40'C (104'F)

Product Label: Exchange Select Chest Congestion & Cough Relief Dm

exchange select

Chest Congestion

& Cough Relief DM

20 Softgels  Ages 12+

Manufactured For Your Military Exchange

By AptaPharma Inc.,

1533 Union Avenue, Pennsauken, NJ 08110

1-877-798-5944

aptapharma.com

res


Structured Label Content

Indications and Usage (34067-9)

Uses

■ helps loosen phlegm (mucus) and thin broochial secretions to make cough more

   productlve

■ temporarily relieves cough due to minor throat and bronchial irritation as may

  occur with a cold

Dosage and Administration (34068-7)

Directions

■ Do not take more than 12 softgels in any 24·hour period

■ This product is nol lntended for use in children under 12 years

■ Adults & children 12 years and over - 2 softgels every 4 hours

■ Children under 12 years of age - do not use

Warnings and Precautions (34071-1)

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.

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 50566-9 (50566-9)

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is

accompanied by fever, rash, or persistent headache. These could be signs of a

serious condition.

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 51727-6 (51727-6)

Inactive ingredients

FD&C Red # 40, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene

glycol, Purified water, Sorbitol sorbllan solulion, Titanium dioxide

Section 53413-1 (53413-1)

Questions? 1-877-798-5944

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Dextromethorphan HBr ..........................Cough Suppressant

Guaifenesin       ....................................Expectorant

Section 55106-9 (55106-9)

Drug Facts



Active ingredients (per softgel)

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Section 60561-8 (60561-8)

Other information

■ Store at room temperature

■ Avoid excessive heat above 40'C (104'F)

Product Label: Exchange Select Chest Congestion & Cough Relief Dm (Product Label: exchange select Chest Congestion & Cough Relief DM)

exchange select

Chest Congestion

& Cough Relief DM

20 Softgels  Ages 12+

Manufactured For Your Military Exchange

By AptaPharma Inc.,

1533 Union Avenue, Pennsauken, NJ 08110

1-877-798-5944

aptapharma.com

res


Advanced Ingredient Data


Raw Label Data

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