1004- Major

1004- Major
SPL v5
SPL
SPL Set ID 78faa497-6743-b85b-e053-2a91aa0ae822
Route
ORAL
Published
Effective Date 2022-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (30 mg)
Inactive Ingredients
Starch, Corn Silicon Dioxide Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose Titanium Dioxide Kaolin Calcium Cation Carnauba Wax Croscarmellose Fd&c Red No. 40 Shellac Stearic Acid Sucrose Food Yellow 3 Free Acid Gelatin Talc

Identifiers & Packaging

Pill Appearance
Imprint: 1004 Shape: round Color: red Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-01-31 Until 2026-12-31

Description

Active ingredient (in each tablet) Pseudoephedrine HCl 30 mg


Medication Information

Description

Active ingredient (in each tablet) Pseudoephedrine HCl 30 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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed®.

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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

calcium sulfate, carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, shellac, silicon dioxide, stearic acid, sucrose, talc, titanium dioxide.

Section 51945-4

MAJOR ®

NDC 0904-6727-60

Non Drowsy SudoGest TM

Nasal Decongestant

Pseudoephedrine Hydrochloride 30mg

FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever without drowsiness

Compare to the active ingredient in Sudafed® Sinus Congestion*

100 Tablets

Section 53414-9

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

Section 55105-1

Purpose

Nasal decongestant

Directions
  • take every 4-6 hours
  • do not take more than 4 doses in 24 hours

adults & children 12 years & over

2 tablets

children 6 to under 12 years

1 tablets

children under 6 years

do not use

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Other Information
  • Store between 15° - 30°C (59° - 86°F)
  • use by expiration date on package
Questions Or Comments?

1-800-616-2471


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

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed®.

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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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)

calcium sulfate, carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, shellac, silicon dioxide, stearic acid, sucrose, talc, titanium dioxide.

Section 51945-4 (51945-4)

MAJOR ®

NDC 0904-6727-60

Non Drowsy SudoGest TM

Nasal Decongestant

Pseudoephedrine Hydrochloride 30mg

FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever without drowsiness

Compare to the active ingredient in Sudafed® Sinus Congestion*

100 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
  • take every 4-6 hours
  • do not take more than 4 doses in 24 hours

adults & children 12 years & over

2 tablets

children 6 to under 12 years

1 tablets

children under 6 years

do not use

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Other Information (Other information)
  • Store between 15° - 30°C (59° - 86°F)
  • use by expiration date on package
Questions Or Comments? (Questions or comments?)

1-800-616-2471


Advanced Ingredient Data


Raw Label Data

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