Indications and uses
temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
Pain Reliever
- Manufacturer
- Lil' Drug Store Products, Inc.
- Effective date
- 2024-12-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:50:15
Label at a glance#
ProductPain Reliever
Active ingredientACETAMINOPHEN
Label structure10 sections
Dosage and administration
Directions do not take more than directed (see Overdose warning) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor
Storage and handling
Other information store between 20° to 25°C (68° to 77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each caplet)
Acetaminophen USP 500 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver Warning
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have 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 a doctor if
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Overdose warning
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
Directions
- do not take more than directed (see Overdose warning)
| adults and children 12 years and over |
|
| children under 12 years | ask a doctor |
Other information
Other information
- store between 20° to 25°C (68° to 77°F)
Inactive ingredients
Inactive ingredients povidone, pregelatinized starch (maize), stearic acid
OTC - QUESTIONS SECTION
Questions or comments?
Call toll-free
1-877-507-6516 (M-F 8AM-4:30PM CST)
SPL UNCLASSIFIED SECTION
**This product is not manufactured or distributed by JOHNSON & JOHNSON CONSUMER, INC., McNeil Consumer Healthcare Division, distributor of Tylenol® Extra Strength Caplets.
PDP/Package
[caduceus]
Compare to the Active
Ingredient in Tylenol®
Extra Strength Caplets**
Extra Strength
Pain Reliever
Acetaminophen 500 mg
Pain Reliever/Fever Reducer
[caplet image]
ACTUAL SIZE
24
Caplets
[Lil' Drug Store logo]
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66715-6867-4 | Pain Reliever | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 66715-6867-4 | Pain Reliever | 24 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 24 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66715-6867 | PAIN RELIEVER (ACETAMINOPHEN 500 MG, FILM-COATED TABLET) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250101_e5f9def4-4cf5-4e06-e053-2995a90a07ea.zip |
Products#
Every source-derived product name is available through these pages.
- Pain Reliever
- Acetaminophen 500 mg, film-coated tablet
- ACETAMINOPHEN
- STARCH, CORN
- POVIDONE K30
- PALMITOSTEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66715-6867 | 66715-6867-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| PALMITOSTEARIC ACID | Q8Y7S3B85M | IACT |
Source Document#
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 |
|---|---|---|---|---|---|---|
| Pain Reliever | ACETAMINOPHEN 500 MG, FILM-COATED TABLET | Lil' Drug Store Products, Inc. | e5f9def4-4cf5-4e06-e053-2995a90a07ea | 2024-12-31 | Warnings | 66715-6867-4 66715-6867 66715686704 2a929624-4394-458a-e063-6394a90afbf2 e5f9def4-4cf5-4e06-e053-2995a90a07ea |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.