Better Living Brands Llc Children’s 12 Hour Cough Relief Drug Facts

Better Living Brands Llc Children’s 12 Hour Cough Relief Drug Facts
SPL v2
SPL
SPL Set ID 62d71572-d157-484a-8676-7ce6da413ee8
Route
ORAL
Published
Effective Date 2022-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg)
Inactive Ingredients
D&c Red No. 30 Fd&c Blue No. 1 Glycerin High Fructose Corn Syrup Methylparaben Polysorbate 80 Polyvinyl Acetate Povidone, Unspecified Propylparaben Water Sodium Metabisulfite Sodium Polystyrene Sulfonate Sucrose Tartaric Acid Tragacanth Triacetin Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
ANDA Active Since 2022-05-27
Description

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Purpose

Cough suppressant

Medication Information

Purpose

Cough suppressant

Description

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Uses

temporarily relieves

  • •
    cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • •
    the impulse to cough to help you get to sleep
Directions
  • •
    shake bottle well before use
  • •
    measure only with dosing cup provided
  • •
    do not use dosing cup with other products
  • •
    dose as follows or as directed by a doctor

adults and children 12 years of age and over

10 mL every 12 hours, not to exceed 20 mL in 24 hours

children 6 to under 12 years of age

5 mL every 12 hours, not to exceed 10 mL in 24 hours

children 4 to under 6 years of age

2.5 mL every 12 hours, not to exceed 5 mL in 24 hours

children under 4 years of age

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.

Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

Other Information
  • •
    each 5 mL contains: sodium 5 mg
  • •
    store at 20° to 25°C (68° to 77°F)
  • •
    dosing cup provided
Inactive Ingredients

artificial grape flavor, D&C Red #30 aluminum lake, FD&C Blue #1 aluminum lake, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Questions Or Comments?

1-800-719-9260

Stop Use and Ask A Doctor If
  • •
    side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • •
    cough lasts more than 7 days, cough 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 (1-800-222-1222).

Active Ingredient (in Each 5 Ml)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Ask A Doctor Before Use If You Have
  • •
    chronic cough that lasts as occurs with smoking, asthma or emphysema
  • •
    cough that occurs with too much phlegm (mucus)
Package/label Principal Display Panel

Compare to Children’s Delsym® active ingredient

Signature Care®

Quality Guaranteed

AGES 4 AND OLDER

Children’s 12 Hour Cough Relief

DEXTROMETHORPHAN POLISTIREX

EXTENDED-RELEASE

ORAL SUSPENSION

Cough Suppressant

GRAPE

-FLAVORED LIQUID

Day or Night

For Children & Adults

• Alcohol-free

• Dosing Cup Included

3 FL OZ (89 mL)

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions

Structured Label Content

Uses

temporarily relieves

  • •
    cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • •
    the impulse to cough to help you get to sleep
Purpose

Cough suppressant

Directions
  • •
    shake bottle well before use
  • •
    measure only with dosing cup provided
  • •
    do not use dosing cup with other products
  • •
    dose as follows or as directed by a doctor

adults and children 12 years of age and over

10 mL every 12 hours, not to exceed 20 mL in 24 hours

children 6 to under 12 years of age

5 mL every 12 hours, not to exceed 10 mL in 24 hours

children 4 to under 6 years of age

2.5 mL every 12 hours, not to exceed 5 mL in 24 hours

children under 4 years of age

do not use
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.

Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

Other Information (Other information)
  • •
    each 5 mL contains: sodium 5 mg
  • •
    store at 20° to 25°C (68° to 77°F)
  • •
    dosing cup provided
Inactive Ingredients (Inactive ingredients)

artificial grape flavor, D&C Red #30 aluminum lake, FD&C Blue #1 aluminum lake, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • •
    side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • •
    cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • •
    chronic cough that lasts as occurs with smoking, asthma or emphysema
  • •
    cough that occurs with too much phlegm (mucus)
Package/label Principal Display Panel (Package/Label Principal Display Panel)

Compare to Children’s Delsym® active ingredient

Signature Care®

Quality Guaranteed

AGES 4 AND OLDER

Children’s 12 Hour Cough Relief

DEXTROMETHORPHAN POLISTIREX

EXTENDED-RELEASE

ORAL SUSPENSION

Cough Suppressant

GRAPE

-FLAVORED LIQUID

Day or Night

For Children & Adults

• Alcohol-free

• Dosing Cup Included

3 FL OZ (89 mL)

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:14.558847 · Updated: 2026-03-14T23:00:36.247175