PAIN RELIEF PM- acetaminophen and diphenhydramine citrate tablet 
Better Living Brands, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Signature Care 44-373

Active ingredients (in each tablet)

Acetaminophen 500 mg
Diphenhydramine citrate 38 mg

Purpose

Pain reliever
Nighttime sleep-aid

Uses

for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings

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

Do not use

  • if you are allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin 

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • liver disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • drowsiness may occur
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery 

Stop use and ask a doctor if

  • sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • painful area is red or swollen

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.

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

Directions

Other information

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, shellac, silica gel, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

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Quality Guaranteed

COMPARE TO
Excedrin® PM Tablets
active ingredients*

NDC 21130-373-15

Pain Relief PM

Acetaminophen 500 mg
DIPHENHYDRAMINE CITRATE 38 mg
Pain Reliever/Nighttime Sleep-Aid

• Aspirin free
• Non-habit forming

Actual Size

50 TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributors of Excedrin® PM Tablets.
50844    REV0414C37315

DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.com

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Signature Care 44-373

Signature Care 44-373

PAIN RELIEF PM 
acetaminophen and diphenhydramine citrate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-373
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE 38 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 44;373
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21130-373-15 1 in 1 CARTON
1 50 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 06/07/2004
Labeler - Better Living Brands, LLC (009137209)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(21130-373)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(21130-373)

Revised: 9/2015
Document Id: 5baeb729-db2e-4e9f-b9d6-8cf217c105c0
Set id: 4ad11374-24e7-4ae5-98ea-60ab407325c5
Version: 6
Effective Time: 20150917
 
Better Living Brands, LLC