Best Choice 44-674

Best Choice 44-674

Drug Labeling and Warnings

Drug Details

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

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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Best Choice 44-674

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
  • facial swelling
  • shock
  • 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 in 24 hours, which is the maximum daily amount
  • 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
  • in children under 12 years of age
  • with any other drug containing acetaminophen (prescription or non prescription). 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

Ask a doctor before use if

  • 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:
  • 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

  • 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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?

1-800-426-9391 

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN EXCEDRIN® PM HEADACHE†

Best Choice®

Headache Relief PM

ACETAMINOPHEN
Aspirin (NSAID)
Diphenhydramine citrate

Pain Reliever / Nighttime Sleep Aid
Caffeine Free

50 Caplets
Non-Habit Forming

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      REV0117A67415

PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO.
5000 KANSAS AVE
KANSAS CITY, KS 66106

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Best Choice 44-674

Best Choice 44-674

HEADACHE RELIEF PM 
acetaminophen, aspirin, diphenhydramine citrate tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63941-674
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE38 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CELLULOSE, MICROCRYSTALLINE (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)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize17mm
FlavorImprint Code 674
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63941-674-151 in 1 CARTON08/31/2016
150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/31/2016
Labeler - Valu Merchandisers Company (868703513)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(63941-674)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(63941-674)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(63941-674)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(63941-674)

Revised: 11/2018
 
Valu Merchandisers Company


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