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- NDC Code(s): 50580-242-01, 50580-242-02, 50580-242-03
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 21, 2023
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
Drug Facts
- Active ingredient (in each tablet)
Pseudoephedrine HCl 120 mg
- Purpose
- Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
- 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
When using this product do not exceed recommended dosage
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
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).
- Directions
adults and children 12 years and over - take 1 tablet every 12 hours
- do not take more than 2 tablets in 24 hours
children under 12 years do not use this product in children under 12 years of age - Other information
- each tablet contains: calcium 45 mg
- store at 20-25°C (68-77°F) in a dry place
- protect from light
- do not use if blister unit is torn or broken
- see carton end panel for lot number and expiration date
- this product meets the requirements of USP Drug Release Test 3
- Inactive ingredients
carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
- Questions or comments?
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
- PRINCIPAL DISPLAY PANEL
PREVIOUSLY SUDAFED ® 12 HOUR
NDC 50580-242-01SUDAFED ®
SINUS
CONGESTION 12 HOURPseudoephedrine HCl Extended-Release Tablets USP, 120 mg
Nasal Decongestantactual size
MAXIMUM STRENGTH
SINUS PRESSURE
+ CONGESTION10 COATED CAPLETS*
*CAPSULE-SHAPED TABLETSNON-DROWSY
- INGREDIENTS AND APPEARANCE
SUDAFED SINUS CONGESTION 12 HOUR
pseudoephedrine hydrochloride tablet, film coated, extended releaseProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-242 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 19mm Flavor Imprint Code SU12 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-242-01 1 in 1 CARTON 06/17/2019 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:50580-242-02 2 in 1 CARTON 06/17/2019 2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:50580-242-03 3 in 1 PACKAGE 06/17/2019 3 1 in 1 CARTON 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075153 06/17/2019 Labeler -Johnson & Johnson Consumer Inc.(878046358)
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SUDAFED SINUS CONGESTION 12 HOUR- pseudoephedrine hydrochloride tablet, film coated, extended release
Number of versions: 3
Published Date (What is this?) | Version | Files |
---|---|---|
Mar 31, 2023 | 3 (current) | download |
Apr 7, 2022 | 2 | download |
Jun 17, 2019 | 1 | download |
RxNorm
SUDAFED SINUS CONGESTION 12 HOUR- pseudoephedrine hydrochloride tablet, film coated, extended release
RxCUI | RxNorm NAME | RxTTY | |
---|---|---|---|
1 | 1049154 | pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet | PSN |
2 | 1049154 | 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet | SCD |
3 | 1049154 | pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet | SY |
4 | 1049668 | SUDAFED 120 MG 12HR Extended Release Oral Tablet | PSN |
5 | 1049668 | 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Sudafed] | SBD |
6 | 1049668 | 12 HR Sudafed 120 MG Extended Release Oral Tablet | SY |
7 | 1049668 | Sudafed 120 MG 12 HR Extended Release Oral Tablet | SY |
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SUDAFED SINUS CONGESTION 12 HOUR- pseudoephedrine hydrochloride tablet, film coated, extended release
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NDC Codes
SUDAFED SINUS CONGESTION 12 HOUR- pseudoephedrine hydrochloride tablet, film coated, extended release
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
NDC | |
---|---|
1 | 50580-242-01 |
2 | 50580-242-02 |
3 | 50580-242-03 |