1215-major

1215-major
SPL v5
SPL
SPL Set ID 78fc7358-75d1-e94a-e053-2a91aa0ab0f1
Route
ORAL
Published
Effective Date 2024-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (60 mg)
Inactive Ingredients
Anhydrous Lactose Croscarmellose Silicon Dioxide Microcrystalline Cellulose Magnesium Stearate Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: CPC Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-31
Description

Active ingredient (in each tablet) Pseudoephedrine HCl 60 mg

Medication Information

Description

Active ingredient (in each tablet) Pseudoephedrine HCl 60 mg

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
Section 34088-5

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

Section 42229-5

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: MAJOR® PHARMACEUTICALS

INDIANAPOLIS, IN 46268

www.majorpharmaceuticals.com

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
Section 50567-7

When using this product do not exceed recommended dose.

Section 50569-3

Ask a doctor before use if you have

  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
Section 50570-1

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.

Section 51727-6

croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica and stearic acid.

Section 51945-4

MAJOR

NDC 0904-6728-46

SudoGest TM

Nasal Decongestant

Pseudoephedrine Hydrochloride 60 mg

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness

30 Tablets

Section 53414-9

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

Section 55105-1

Purpose

Nasal decongestant

Directions
  • adults and children 12 years and older: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
  • children under 12 years of age: do not use
Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 60 mg

Other Information
  • store in a dry place at 15° – 30°C (59° – 86°F)
  • use by expiration date on package
Questions Or Comments?

(800) 231-4670

Structured Label Content

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: MAJOR® PHARMACEUTICALS

INDIANAPOLIS, IN 46268

www.majorpharmaceuticals.com

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with a fever
Section 50567-7 (50567-7)

When using this product do not exceed recommended dose.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica and stearic acid.

Section 51945-4 (51945-4)

MAJOR

NDC 0904-6728-46

SudoGest TM

Nasal Decongestant

Pseudoephedrine Hydrochloride 60 mg

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever Without Drowsiness

30 Tablets

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Nasal decongestant

Directions
  • adults and children 12 years and older: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
  • children under 12 years of age: do not use
Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 60 mg

Other Information (Other information)
  • store in a dry place at 15° – 30°C (59° – 86°F)
  • use by expiration date on package
Questions Or Comments? (Questions or comments?)

(800) 231-4670

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:02.694405 · Updated: 2026-03-14T23:02:54.359020