Indications and uses
temporarily relieves minor aches and pains due to: backache muscular aches headache the common cold toothache minor pain of arthritis premenstrual and menstrual cramps temporarily reduces fever
Pain Reliever
- Manufacturer
- Chain Drug Consortium | LNK International, Inc.
- Effective date
- 2020-03-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:39:01
Label at a glance#
ProductPain Reliever Extra Strength
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not take more than directed adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: ask a doctor
Storage and handling
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Websitewww.emersongroup.com
www.emersongroup.com
www.emersongroup.comLabel contents#
Full prescribing information#
Active ingredient (in each tablet)
Acetaminophen 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- backache
- muscular aches
- headache
- the common cold
- toothache
- minor pain of arthritis
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg 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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- blisters
- rash
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
liver disease.
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
Stop use and ask a doctor if
- 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
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed
- adults and children 12 years and over
- take 2 tablets every 6 hours while symptoms last
- do not take more than 6 tablets in 24 hours, unless directed by a doctor
- do not take for more than 10 days unless directed by a doctor
- children under 12 years: ask a doctor
Other information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, D&C yellow #10 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
Questions or comments?
1-800-426-9391
Principal Display Panel
Premier
Value®
NDC 68016-636-10
*COMPARE TO THE ACTIVE INGREDIENT IN
EXTRA STRENGTH TYLENOL®
Extra Strength
Pain Reliever
Acetaminophen 500 mg
PAIN RELIEVER/FEVER REDUCER
100 Tablets
Non aspirin
Easy to swallow
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087www.emersongroup.com
*This product is not manufactured or
distributed by McNeil Consumer Healthcare,
owner of the registered trademark Extra
Strength Tylenol®. 50844 REV0816A53112
PV
Independently Tested
Satisfaction Guaranteed
If for any reason you are not satisfied with
this product, please return it to the store
where purchased for a full refund.
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| DEXTROSE MONOHYDRATE | INACTIVE INGREDIENT | LX22YL083G | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Products#
Every source-derived product name is available through these pages.
- Pain Reliever Extra Strength
- Acetaminophen
- STARCH, CORN
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- POVIDONE, UNSPECIFIED
- STEARIC ACID
- SUCRALOSE
- TITANIUM DIOXIDE
- D&C YELLOW NO. 10
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ALCOHOL, UNSPECIFIED
- TALC
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68016-636 | 68016-636-10, 68016-636-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, DELAYED RELEASE / ORAL | 216 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | LOZENGE / ORAL | 175 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, FILM COATED / ORAL | 1 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE / ORAL | 5785 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION/ DROPS / ORAL | 90 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / ORAL | 60.02 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / SUBLINGUAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SOLUTION / ORAL | 414 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TROCHE / ORAL | 60 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| DEXTROSE MONOHYDRATE | DEXTROSE MONOHYDRATE | LX22YL083G | TROCHE / ORAL | 4440 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SOLUTION / ORAL | 3000 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, ORALLY DISINTEGRATING / ORAL | 12 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, COATED / ORAL | 3.17 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | TABLET, EFFERVESCENT / ORAL | 14404 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| DEXTROSE MONOHYDRATE | DEXTROSE MONOHYDRATE | LX22YL083G | SPRAY, METERED / NASAL | 20 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SUSPENSION / OPHTHALMIC | 1.8 %w/v | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | POWDER, FOR SUSPENSION / ORAL | 34 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / RECTAL | 0.5 %w/v | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | FILM, SOLUBLE / ORAL | 19 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MALTODEXTRIN | MALTODEXTRIN | 7CVR7L4A2D | CAPSULE / ORAL | 200 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 17 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SUSPENSION / ORAL | 6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, EXTENDED RELEASE / ORAL | 8 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY, METERED / NASAL | 2 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE / ORAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION, EXTENDED RELEASE / ORAL | 16 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET / SUBLINGUAL | 12 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SYRUP / ORAL | 3 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, COATED / ORAL | 49.2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM, SOLUBLE / ORAL | 33 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | DROPS / ORAL | NA | ||
| DEXTROSE MONOHYDRATE | DEXTROSE MONOHYDRATE | LX22YL083G | TABLET / ORAL | 11 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f1f403ad-0939-4aa9-b040-ab01289d7a64 | f29705e5-2cdb-44d9-bea9-6cffb745a423 | 2020-03-26 | Warnings | f1f403ad-0939-4aa9-b040-ab01289d7a64 f29705e5-2cdb-44d9-bea9-6cffb745a423 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.