PAIN RELIEF PM- acetaminophen, aspirin, diphenhydramine citrate tablet, film coated 
Amerisource Bergen

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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Good Neighbor Pharmacy 44-674

Active ingredients

Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Diphenhydramine citrate 38 mg
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever
Pain reliever
Nighttime sleep-aid

Uses

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

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

Do not use

  • if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
  • 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

Ask a doctor before use if you have

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have glaucoma
  • you have asthma
  • you have difficulty in urination due to enlargement of the prostate gland
  • you are taking a diuretic
  • you have a breathing problem such as emphysema or chronic bronchitis
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

Ask a doctor or pharmacist before use if you are taking

  • a prescription drug for:
  • diabetes
  • gout
  • arthritis
  • any other drug, or are under a doctor’s care for any serious condition
  • sedatives or tranquilizers
  • any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

When using this product

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

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain gets worse or lasts for more than 10 days
  • painful area is red or swollen
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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

Other information

Inactive ingredients

corn starch, crospovidone, FD&C blue #1 aluminum lake, hypromellose, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polydextrose, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium sulfate, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate

Questions or comments?

1-800-426-9391

Principal display panel

 GOOD
 NEIGHBOR
 PHARMACY®

Compare to Excedrin® PM Headache active ingredients†

NDC 46122-456-71

Pain Relief PM
acetaminophen

aspirin (NSAID) & diphenhydramine citrate

Pain Reliever / Nighttime Sleep Aid

Caffeine free

50 Caplets ι • Non-habit forming

Actual Size

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

†This product is not manufactured or distributed by Novartis
AG, owner of the registered trademark Excedrin® PM Headache.

50844       ORG011767415

Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
Questions or Concerns?
www.mygnp.com

GOOD NEIGHBOR PHARMACY BRAND PRODUCTS
SATISFACTION GUARANTEED

Good Neighbor Pharmacy 44-674

Good Neighbor Pharmacy 44-674

PAIN RELIEF PM 
acetaminophen, aspirin, diphenhydramine citrate tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-456
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE 38 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ZINC STEARATE (UNII: H92E6QA4FV)  
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 674
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:46122-456-71 1 in 1 CARTON 08/31/2016
1 50 in 1 BOTTLE; 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 08/31/2016
Labeler - Amerisource Bergen (007914906)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(46122-456)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 868734088 PACK(46122-456)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(46122-456)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 967626305 PACK(46122-456)

Revised: 12/2017
Document Id: 20642a47-76e6-4512-bc1a-50c2b6aec8ae
Set id: f56c438a-0593-421f-8a7c-903d1874c8ea
Version: 1
Effective Time: 20171207
 
Amerisource Bergen