![PAIN RELIEVER REGULAR STRENGTH (ACETAMINOPHEN) TABLET [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)]](https://medic.hrt.org//dailymed/images/420ecd19-f156-49ad-872a-161604480e59/acetaminophen-325-mg-1.jpg)
| NDC | 55910-691-10 |
| Set ID | 420ecd19-f156-49ad-872a-161604480e59 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
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
- 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
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Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over - take 2 tablets every 4 to 6 hours while symptoms last
- do not take more than 10 tablets in 24 hours
- do not use for more than 10 days unless directed by a doctor
children 6-11 years - take 1 tablet every 4 to 6 hours while symptoms last
- do not take more than 5 tablets in 24 hours
- do not use for more than 5 days unless directed by a doctor
children under 6 years - ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to the active ingredient of Tylenol® Regular Strength**
Regular Strength
Pain Reliever
Acetaminophen 325 mg
Pain Reliever/ Fever Reducer
For ages 6 years and over
Tablets
**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Regular Strtength.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
- Product Label
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INGREDIENTS AND APPEARANCE
PAIN RELIEVER REGULAR STRENGTH
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-691 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color WHITE Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL340 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-691-10 1 in 1 BOX 04/30/2018 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 04/30/2018 Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)
