FDA.reportPublic FDA data

ACETA-GESIC

Manufacturer
Rugby Laboratories | TIME CAP LABS, INC. | TIME-CAP LABS, INC
Effective date
2014-06-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:35:51

Label at a glance#

ProductACETA-GESIC
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - DO NOT USE SECTION


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.

with any other product containing diphenhydramine, even one used on skin

OTC - ASK DOCTOR SECTION

Ask doctor or pharmacist before use if you are:

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  •  liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

OTC - STOP USE SECTION

Stop use and ask a doctor if:

pain persists for more than 10 days; fever persists for more than 3 days (unless directed by a doctor); conditions worsen or new symptoms appear; redness or swelling is present.  These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or nursing, as with any drug, seek the advice of a health professional before using this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children

DOSAGE & ADMINISTRATION SECTION

Directions:

  • adults and children 12 years and over: take 1 or 2 tablets every six hours while symptoms last. Maximum daily dose is 8 tablets in 24 hours unless directed by a doctor.
  • children under 12 years: Do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems

INDICATIONS & USAGE SECTION

Uses: temporarily relieves minor aches and pains due to: headache, backache, muscular aches, arthritis pain, colds, flu, fever, toothache, premenstrual cramps.

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, crospovidone, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid

OTC - ACTIVE INGREDIENT SECTION

Each tablet contains:

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

OTC - PURPOSE SECTION

Pain Reliever-Fever Reducer-Antihistamine

WARNINGS SECTION

Warnings:

Liver warning: This product contains acetaminophen. Sever liver damage may occur if: adult or child 12 years and older takes more than 8 tablets in 24 hours, which is the maximum daily amount; taking with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100label100label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1003-01EA - Each0536-1003ebcee90c-6706-4ae0-9e53-b812bd98daa512014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD402
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
CROSPOVIDONEINACTIVE INGREDIENT68401960MK2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A82
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP2
POVIDONEINACTIVE INGREDIENTFZ989GH94E2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJ2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-10030536-1003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
COLLOIDAL SILICON DIOXIDEETJ7Z6XBU4IACT
CROSPOVIDONE68401960MKIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
POVIDONEFZ989GH94EIACT
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 285 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MINERAL OILMINERAL OILT5L8T28FGPDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPPASTE / TOPICAL47.5 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESYSTEM / TOPICAL41 mgExact identifier — unii candidate
30 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED PELLETS / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE / ORAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
28 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EDROPS / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJPOWDER, FOR SUSPENSION / ORAL34 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET / ORAL113.75 mgExact identifier — unii candidate
30 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / INTRAVITREALNAExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
30 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1576 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8GEL / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJTABLET, EXTENDED RELEASE / ORAL184 mgExact identifier — unii candidate
22 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii candidate
34 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8FILM / SUBLINGUAL0.03 mgExact identifier — unii candidate
34 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOGRANULE / ORAL45 mgExact identifier — unii candidate
27 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8DROPS / ORAL0.2 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii candidate
22 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESOLUTION / OPHTHALMIC1.8 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8POWDER / ORAL20 mgExact identifier — unii candidate
34 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CREAM / TOPICALNAExact identifier — unii candidate
39 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / OPHTHALMIC0.5 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING / ORAL1800 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
30 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii candidate
30 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, COATED PELLETS / ORAL456 mgExact identifier — unii candidate
28 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates

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
d22db5f2-49d3-409e-a460-4e09b53f90f8d94be01d-82b4-4419-8f12-e76b5c92f52d2014-06-30WarningsExact identifier
spl id: d22db5f2-49d3-409e-a460-4e09b53f90f8
spl set id: d94be01d-82b4-4419-8f12-e76b5c92f52d

Reported adverse events (FAERS/openFDA)#

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