![PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [BETTER LIVING BRANDS, LLC]](https://medic.hrt.org//dailymed/images/58894f98-6d11-4e2f-bf50-d2890f5cc70e/signature-care-44-556-1.jpg)
| NDC | 21130-556-09, 21130-556-31 |
| Set ID | 58894f98-6d11-4e2f-bf50-d2890f5cc70e |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Better Living Brands, LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each gelcap)
- Purpose
- Uses
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Warnings
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: 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.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- 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
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic beverages
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
- Directions
- Other information
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Inactive ingredients
ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide
- Questions or comments?
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Principal Display Panel
Signature™
care
Quality GuaranteedCOMPARE TO Extra Strength Tylenol® PM
active ingredients*NDC 21130-556-09
Extra Strength
Pain Relief PM
ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE HCl 25 mg
Pain Reliever - Nighttime Sleep-Aid• Aspirin free
• Non-habit formingRAPID RELEASE
Actual Size
20 GELCAPS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING*This product is not manufactured or distributed by Johnson &
Johnson Corporation, distributors of Extra Strength Tylenol® PM.
50844 REV0417A55609DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.comOUR PROMISE
QUALITY & SATISFACTION
100% GUARANTEED
OR YOUR MONEY BACK.
Signature Care 44-556
-
INGREDIENTS AND APPEARANCE
PAIN RELIEF PM EXTRA STRENGTH
acetaminophen and diphenhydramine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-556 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 3 (UNII: PN2ZH5LOQY) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SHELLAC (UNII: 46N107B71O) AMMONIA (UNII: 5138Q19F1X) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color blue (light) , blue (dark) Score no score Shape OVAL Size 20mm Flavor Imprint Code L;6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-556-09 1 in 1 CARTON 12/17/2007 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:21130-556-31 1 in 1 CARTON 12/17/2007 2 80 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 12/17/2007 Labeler - Better Living Brands, LLC (009137209) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(21130-556) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(21130-556) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(21130-556) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(21130-556) , pack(21130-556)