Niaflu (hhh)

Niaflu (hhh)
SPL v2
SPL
SPL Set ID 399898f0-e40a-4f5d-e063-6294a90a667d
Route
ORAL
Published
Effective Date 2025-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Glycerin Polyethylene Glycol 400 Gelatin Povidone K30 Propylene Glycol Water Sorbitol Titanium Dioxide 1,4-sorbitan Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Imprint: AC3 Shape: capsule Color: yellow Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-10

Description

.

Purpose

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Medication Information

Purpose

.

Description

.

Uses

Temporarily alleviates common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to
  • drain bronchial tubes
  • make coughs more productive
Section 51945-4

Section 55105-1
Active ingredients (in each softgel) Purposes
Dextromethorphan HBr 20 mg ...... Cough suppressant
Guaifenesin 400 mg ..... Expectorant

Warnings

Directions
  • do not take more than 6 softgels in a 24 hour period
Age Dose
adults and children 12 years and older 1 softgel, 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.
Dist. By/ Por:

PHARMADEL LLC

New Castle, DE, 19720

+1-866-359-3478

Other Information
  • store between 68-77°F (20-25°C)
  • do not use if blister pack is torn or punctured
Inactive Ingredients

gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone k30, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide, water

Questions Or Comments?

+1-866-359-3478(M-F) 9 AM - 5 PM EST or www.pharmadel.com

Stop Use and Ask A Doctor If
  • cough persists for more than 7 days, tends to recur, 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.

Keep Out of Reach of Children.

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

Active Ingredients and Purposes

.

Ask A Doctor Before Use If You Have
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

Structured Label Content

Uses

Temporarily alleviates common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to
  • drain bronchial tubes
  • make coughs more productive
Section 51945-4 (51945-4)

Section 55105-1 (55105-1)
Active ingredients (in each softgel) Purposes
Dextromethorphan HBr 20 mg ...... Cough suppressant
Guaifenesin 400 mg ..... Expectorant

Warnings

Directions
  • do not take more than 6 softgels in a 24 hour period
Age Dose
adults and children 12 years and older 1 softgel, every 4 hours
children under 12 years 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.
Dist. By/ Por: (Dist. by/ por:)

PHARMADEL LLC

New Castle, DE, 19720

+1-866-359-3478

Other Information (Other information)
  • store between 68-77°F (20-25°C)
  • do not use if blister pack is torn or punctured
Inactive Ingredients (Inactive ingredients)

gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone k30, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide, water

Questions Or Comments? (Questions or comments?)

+1-866-359-3478(M-F) 9 AM - 5 PM EST or www.pharmadel.com

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. 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.

Active Ingredients and Purposes

.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)