CERTI-CET PLUS

Manufacturer
Certified Safety Manufacturing
Effective date
2018-04-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:59:39

Label at a glance#

ProductCERTI-CET PLUS Extra Strength
Active ingredientAcetaminophen
Label structure10 sections

Indications and uses

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

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Analgesic/Antipyretic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if user has liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask doctor if

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • ask a health professional before use.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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.

SPL UNCLASSIFIED SECTION

Do not exceed recommended dosage.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

May contain providone and sodium starch glycolates.

Questions?

OTC - QUESTIONS SECTION

Call 1-800-854-7474

PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Box
PRINCIPAL DISPLAY PANEL - 500 mg Tablet Pouch Box

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48083-31048083-310-27, 48083-310-30, 48083-310-33, 48083-310-36, 48083-310-39, 48083-310-31

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4fa9ec4e-b34c-48eb-979b-63d0fc409c3edcca9568-8eb5-4d70-a312-e6e1082f99722025-01-31WarningsExact identifier
spl set id: dcca9568-8eb5-4d70-a312-e6e1082f9972

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.