Label: CERTI-SINE- phenylephrine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 48083-330-27, 48083-330-30, 48083-330-31, 48083-330-33, view more48083-330-36, 48083-330-39, 48083-330-41 - Packager: Certified Safety Manufacturing
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 12, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients (each tablet)
- Purpose
- Uses
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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 health professional before taking this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland.
Stop use and ask a doctor if
- new symptoms occur
- symptoms do not improve within 7 days
- redness or swelling are present
- you get nervous, dizzy or sleepless.
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 5 mg Tablet Pouch Box
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INGREDIENTS AND APPEARANCE
CERTI-SINE
phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48083-330 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) D&C RED NO. 27 (UNII: 2LRS185U6K) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SHELLAC (UNII: 46N107B71O) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color RED Score no score Shape ROUND Size 7mm Flavor Imprint Code 271 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48083-330-27 25 in 1 BOX 12/29/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:48083-330-30 50 in 1 BOX 12/29/2017 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:48083-330-33 125 in 1 BOX 12/29/2017 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:48083-330-36 250 in 1 BOX 12/29/2017 4 2 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:48083-330-39 500 in 1 BOX 12/29/2017 5 2 in 1 POUCH; Type 0: Not a Combination Product 6 NDC:48083-330-41 1000 in 1 BOX 12/29/2017 6 2 in 1 POUCH; Type 0: Not a Combination Product 7 NDC:48083-330-31 50 in 1 BOX 12/29/2017 7 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 12/29/2017 Labeler - Certified Safety Manufacturing (788460483)