yet - bare & better cough relief - dextromethorphan hbr 15 mg

yet - bare & better cough relief - dextromethorphan hbr 15 mg
SPL v5
SPL
SPL Set ID f4f4c498-42d7-4cc5-8fd2-4f6837a3f57b
Route
oral
Published
Effective Date 2021-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
dextromethorphan (15 mg)
Inactive Ingredients
fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol 400 propylene glycol povidone water sorbitol solution 70% sorbitan sorbitol titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: IS3 Shape: oval Color: red Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-05-05

Purpose

Cough suppressant

Description

Dextromethorphan HBr 15 mg


Medication Information

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 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.

Ask a doctor before use if you have

  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

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.

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

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Purpose

Cough suppressant

Directions
  • do not take more than 8 capsules in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
 adults and children 12 years and older  take 2 capsults every 6 to 8 hours, as needed
 children under 12 years  do not use

Other Information
  • store between 20˚ and 25˚C (68˚ -77˚F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light

Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, purified water, sorbitol 70% solution, sorbitol sorbitan solution, titanium dioxide.

Description

Dextromethorphan HBr 15 mg

Questions?

call 1-844-735-0202

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51945-4

Active Ingredient

Dextromethorphan HBr 15 mg


Structured Label Content

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 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.

Ask a doctor before use if you have

  • a cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic as occurs with smoking, asthma, or emphysema

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.

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

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Purpose

Cough suppressant

Directions
  • do not take more than 8 capsules in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
 adults and children 12 years and older  take 2 capsults every 6 to 8 hours, as needed
 children under 12 years  do not use

Other Information (Other information)
  • store between 20˚ and 25˚C (68˚ -77˚F)
  • avoid excessive heat above 40°C (104°F)
  • protect from light

Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone, purified water, sorbitol 70% solution, sorbitol sorbitan solution, titanium dioxide.

Questions?

call 1-844-735-0202

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Dextromethorphan HBr 15 mg


Advanced Ingredient Data


Raw Label Data

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