CERTI-SINE- phenylephrine hydrochloride tablet

CERTI-SINE by

Drug Labeling and Warnings

CERTI-SINE by is a Otc medication manufactured, distributed, or labeled by Certified Safety Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (each tablet)

Phenylephrine HCl 5 mg

Purpose

Nasal decongestant

Uses

• For the temporary relief of nasal congestion due to a cold, hay fever or other upper respiratory allergies associated with sinusitis.
• Temporarily relieves stuffy nose, 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 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.

If pregnant or breast-feeding

• ask a health professional before use.

Keep out of the reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not exceed recommended dosage.

Directions

• Adults and children 12 years of age and older: Take 2 tablets every 4 hours as needed. ; Do not take more than 12 tablets in 24 hours.
• Children under 12 years of age: Do not use this adult strength product without first speaking to your doctor.

Other information

• read all product information before using
• store at room temperature 59-86°F (15-30°C)
• use by expiration date on package.

Inactive ingredients

• Colloidal silica, croscarmellose sodium, dicalcium phosphate, D & C Red #27 Lake, Magnesium Stearate, microcrystalline cellulose, pharmaceutical glaze, pregelatinized starch, stearic acid, talc.

Questions?

Call 1-800-854-7474

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Pouch Box

Tamper evident
packaging:
Do not use if
open or torn.

This package for
households
without children

See New Warnings
Information

Compare to Sudafed PE ®
CERTI-SINE™
5 mg Phenylephrine HCl

• Nasal
  Decongestant

INGREDIENTS AND APPEARANCE

CERTI-SINE 
phenylephrine hydrochloride tablet

Product 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)