Premier Value Arthritis Pain Reliever

Manufacturer
Chain Drug Consortium, LLC | Ranbaxy Pharmaceuticals Inc. | Ohm Laboratories Limited
Effective date
2015-10-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:43:51

Label at a glance#

ProductPremier Value Arthritis Pain Reliever
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

• temporarily relieves minor aches and pains due to: • muscular aches • backache • headache • toothache • the common cold • minor pain of arthritis • premenstrual and menstrual cramps • temporarily reduces fever

Dosage and administration

• do not take more than directed (see overdose warning) adults ▪ take 2 geltabs every 8 hours. Swallow only one geltab at a time. ▪ take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass). ▪ swallow whole - do not crush, chew, split or dissolve ▪ do not take more than 6 geltabs in 24 hours ▪ do not use for more than 10 days unless directed by a doctor under...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH GELTAB)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen USP, 650 mg

PURPOSE

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USES

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • backache
    • headache
    • toothache
    • the common cold
    • minor pain of arthritis
    • premenstrual and menstrual cramps
  • temporarily reduces fever

WARNINGS

WARNINGS SECTION

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

  • more than 6 geltabs in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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.
  • if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • the tablet got stuck in your throat

These could be signs of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)

adults

▪ take 2 geltabs every 8 hours. Swallow only one geltab at a time.
▪ take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 geltabs in 24 hours
▪ do not use for more than 10 days unless directed by a doctor

under 18 years of age

▪ ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • store at 20 - 25° C (68 - 77° F). Avoid high humidity.
  • see end panel for batch number and expiration date
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, gelatin, glycerin, hypromellose, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, starch, titanium dioxide

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier Value®

NDC 68016-340-08

Use only as directed.

See New Warnings Information

EASY TO OPEN BOTTLE

Lasts up to 8 hours

Arthritis Pain Relief

Acetaminophen Extended-Release Tablets, USP 650 mg

Pain Reliever/Fever Reducer

For the Temporary Relief of Minor Arthritis Pain

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

80 GELTABS* 650 mg EACH

(*Gelatin-Coated Tablets)

COMPARE TO THE ACTIVE INGREDIENT OF TYLENOL®ARTHRITIS PAIN†

DISTRIBUTED BY CHAIN DRUG CONSORTIUM

5095711/0512

This is the bottle carton label for Premier Value 80 count Acetaminophen extended-release tablets, USP 650 mg (geltabs).
This is the bottle carton label for Premier Value 80 count Acetaminophen extended-release tablets, USP 650 mg (geltabs).

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN2
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD2
11483998 HR APAP 650 MG Extended Release Oral TabletSY2
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-340-082020-01-31C16284748780-19d75b9d0-4e7c-f424-e053-dadaa90a57ceDrug Facts
68016-340-402020-01-31C16284748780-19d75b9d0-4e7c-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-340-08Premier Value Arthritis Pain Reliever80 in 1 BOTTLETABLET, EXTENDED RELEASE802
68016-340-40Premier Value Arthritis Pain Reliever40 in 1 BOTTLETABLET, EXTENDED RELEASE402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-340PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2Legacy NDC, 2 package rows20151014_e12098ad-8af1-45f3-817a-62dda19a9449.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-340-08EA - Each68016-340ba65574e-3731-4d4e-bf8d-4d1ee7f0477612014-07-02
68016-340-40EA - Each68016-3404e968dbd-0441-4995-b092-22f73a9df50712014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH482
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3572
GELATININACTIVE INGREDIENT2G86QN327L2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A2
POVIDONESINACTIVE INGREDIENTFZ989GH94E2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2

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
68016-34068016-340-08, 68016-340-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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 7 · 399 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, COATED / ORAL49.2 mgExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO / TOPICAL65 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO, SUSPENSION / TOPICAL40 %w/vExact identifier — unii candidate
42 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30IMPLANT / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, LIQUID FILLED / ORAL12 mgExact identifier — unii candidate
40 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / BUCCAL16.6 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE, DELAYED RELEASE / ORAL366 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
39 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii candidate
42 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
44 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTSUSPENSION / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAVENOUS20 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JLOTION / TOPICAL111 mgExact identifier — unii candidate
42 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, EXTENDED RELEASE / ORAL194 mgExact identifier — unii candidate
22 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94EFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
30 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSOAP / TOPICAL1 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPELLET / ORAL2 mgExact identifier — unii candidate
42 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL47 mgExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii candidate
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LWAFER / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii candidate
28 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED PELLETS / ORAL1 mgExact identifier — unii candidate
42 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCONCENTRATE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48CAPSULE, DELAYED RELEASE PELLETS / ORAL127 mgExact identifier — unii candidate
22 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii candidate
44 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION, EXTENDED RELEASE / ORAL1120 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94EGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
30 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
27 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / ORAL100 mgExact identifier — unii candidate
44 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE / ORAL127 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED / ORAL288 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAMUSCULAR16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE, COATED PELLETS / ORAL10.03 mgExact identifier — unii candidate
30 equally ranked IID candidates
GELATINGELATIN2G86QN327LELIXIR / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
30 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, FOR SUSPENSION / ORAL2 mgExact identifier — unii candidate
30 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, DELAYED RELEASE / ORAL789.6 mgExact identifier — unii candidate
28 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078569-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-1484e616aacf4f…
2026-08-18 06:07:402026-07A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-143f01610625f2…
2019-09-15 20:21 UTC2019-09A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14f41ea6bd6efb…

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
f7294172-76af-4571-a424-ebf27a43f67ce12098ad-8af1-45f3-817a-62dda19a94492015-10-05WarningsExact identifier
spl id: f7294172-76af-4571-a424-ebf27a43f67c
spl set id: e12098ad-8af1-45f3-817a-62dda19a9449

Reported adverse events (FAERS/openFDA)#

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