HEADACHE RELIEF PM- acetaminophen, aspirin, diphenhydramine citrate tablet, film coated

Headache Relief PM by

Drug Labeling and Warnings

Headache Relief PM by is a Otc medication manufactured, distributed, or labeled by DOLGENCORP, LLC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

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: 

• hives
  
• shock
• facial swelling
• asthma (wheezing)
  

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

• blisters
• rash
• skin reddening
  

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

• more than 4,000 mg of acetaminophen in 24 hours
  
• 3 or more alcoholic drinks every day while using this product
  
• with other drugs containing acetaminophen

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

• are age 60 or older
  
• have 3 or more alcoholic drinks every day while using this product
• have had stomach ulcers or bleeding problems
  
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  
• take more or for a longer time than directed
  
• take a blood thinning (anticoagulant) or steroid drug

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  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

• 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 liver disease
  
• 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:
  • arthritis
  • diabetes
  • gout
    
• 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

• avoid alcoholic beverages
• drowsiness may occur
  
• do not drive a motor vehicle or operate machinery
  

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
    
• 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.
  
• pain gets worse or lasts for more than 10 days
  
• redness or swelling is present
• new symptoms occur
  

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

• do not take more than directed
  
• adults and children 12 years and over: take 2 caplets at bedtime, with a full glass of water
  
• do not take more than 2 caplets in 24 hours, unless directed by a doctor
  
• children under 12 years: do not use
  

Other information

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• see end flap for expiration date and lot number
  

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?

1-888-309-9030

Principal display panel

DG™ health

Compare to active
ingredients of Excedrin®
PM Headache**

Headache Relief PM
Acetaminophen
Aspirin (NSAID)
Diphenhydramine citrate

Pain Reliever/Nighttime Sleep Aid

 Caffeine free  Non-habit forming

50 Caplets

Actual Caplet Size

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

50844 ORG041867415

DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

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

DG Health 44-674

INGREDIENTS AND APPEARANCE

HEADACHE RELIEF PM 
acetaminophen, aspirin, diphenhydramine citrate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-674
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--ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SODIUM SULFATE (UNII: 0YPR65R21J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ZINC STEARATE (UNII: H92E6QA4FV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

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: 55910-674-15	1 in 1 CARTON	08/31/2016
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	08/31/2016

Labeler - DOLGENCORP, LLC (068331990)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(55910-674)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(55910-674)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(55910-674)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(55910-674)