CERTI-CET PLUS EXTRA STRENGTH- acetaminophen tablet

CERTI-CET PLUS by

Drug Labeling and Warnings

CERTI-CET PLUS 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)

Acetaminophen 500 mg

Purpose

Analgesic/Antipyretic

Uses

• Temporary relief of minor aches and pains associated with:
  • common colds
  • headache
  • toothache
  • muscular aches
  • backache
  • arthritis
  • menstrual cramps
• and reduction of fever.

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 8 tablets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday while using this product.

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if user has liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask doctor if

• symptoms do not improve
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• new symptoms occur
• redness or swelling is present
• a rare sensitivity reaction occurs.

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 to 6 hours as needed.; Do not take more than 8 tablets in 24 hours.
• Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other information

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

Inactive ingredients

• corn starch, hydroxypropyl methylcellulose, pregelatinized starch, stearic acid, titanium dioxide.

May contain providone and sodium starch glycolates.

Questions?

Call 1-800-854-7474

PRINCIPAL DISPLAY PANEL - 500 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 Tylenol®

CERTI-CET
PLUS™

EXTRA STRENGTH
500 mg Acetaminophen

• Pain Reliever
• Fever Reducer
• Analgesic
• Antipyretic

INGREDIENTS AND APPEARANCE

CERTI-CET PLUS   EXTRA STRENGTH
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48083-310
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	500 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
Stearic Acid (UNII: 4ELV7Z65AP)
Titanium Dioxide (UNII: 15FIX9V2JP)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	AZ;235
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48083-310-27	25 in 1 BOX	12/29/2017
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 48083-310-30	50 in 1 BOX	12/29/2017
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 48083-310-33	125 in 1 BOX	12/29/2017
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 48083-310-36	250 in 1 BOX	12/29/2017
4		2 in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 48083-310-39	500 in 1 BOX	12/29/2017
5		2 in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 48083-310-31	50 in 1 BOX	12/29/2017
6		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 NOT FINAL	part343	12/29/2017

Labeler - Certified Safety Manufacturing (788460483)