GOOD NEIGHBOR PHARMACY PAIN RELIEF AND PAIN RELIEF PM- acetaminophen, diphenhydramine hcl 
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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Amerisource Bergen Pain Relief and Pain Relief PM Drug Facts

Active ingredient (in each caplet) (For Pain Relief)

Acetaminophen 500 mg

Active ingredient (in each caplet) (For Pain Relief PM)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Purpose (For Pain Relief)

Pain reliever/fever reducer

Purpose (For Pain Relief PM)

Pain reliever

Nighttime sleep aid

Uses (For Pain Relief)

temporarily relieves minor aches and pains due to:
the common cold
headache
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps
temporarily reduces fever

Uses (For Pain Relief PM)

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

Warnings (For Pain Relief)

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

more than 8 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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.

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warnings (For Pain Relief PM)

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

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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

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

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 will occur
avoid alcoholic drinks
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 serious underlying medical illness.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions (For Pain Relief)

do not take more than directed (see Liver warning)

Adults and children 12 years and over:

take 2 caplets every 6 hours while symptoms last
do not take more than 8 caplets in 24 hours

Children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Directions (For Pain Relief PM)

do not take more than directed (see Liver warning)

Adults and children 12 years and over:

take 2 caplets at bedtime
do not take more than 2 caplets of this product in 24 hours

Children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Inactive ingredients (For Pain Relief)

carnauba wax*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, sodium metabisulfite*, sodium starch glycolate*, stearic acid *may contain one or more of these ingredients

Inactive ingredients (For Pain Relief PM)

carnauba wax, crospovidone, FD&C blue no. 1, FD&C blue no. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments? (For Pain Relief and Pain Relief PM)

1-800-719-9260

Principal Display Panel

See New Warnings Information

COMPARE TO ACTIVE INGREDIENT IN EXTRA STRENGTH TYLENOL® CAPLETS

EXTRA STRENGTH

PAIN RELIEF

CAPLETS

ACETAMINOPHEN

Pain Reliever / Fever Reducer

500 mg EACH

See New Warnings Information

COMPARE TO ACTIVE INGREDIENTS IN EXTRA STRENGTH TYLENOL® PM CAPLETS

EXTRA STRENGTH

PAIN RELIEF PM

ACETAMINOPHEN, DIPHENHYDRAMINE HCl

Pain Reliever / Nighttime Sleep Aid

Extra Strength Pain Relief and Extra Strength Pain Relief PM Carton Image 1

Extra Strength Pain Relief and Extra Strength Pain Relief PM Carton Image 1

Extra Strength Pain Relief and Extra Strength Pain Relief PM Carton Image 2

Extra Strength Pain Relief and Extra Strength Pain Relief PM Carton Image 1

Extra Strength Pain Relief and Extra Strength Pain Relief PM Carton Image 2

GOOD NEIGHBOR PHARMACY PAIN RELIEF AND PAIN RELIEF PM 
acetaminophen, diphenhydramine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-987
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24385-987-811 in 1 CARTON; Type 0: Not a Combination Product09/05/200710/01/2012
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 50 
Part 21 BOTTLE 50 
Part 1 of 2
GOOD NEIGHBOR PHARMACY PAIN RELIEF 
acetaminophen tablet
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (Caplet) Size16mm
FlavorImprint Code L484
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
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 finalpart34309/05/200710/01/2012
Part 2 of 2
GOOD NEIGHBOR PHARMACY PAIN RELIEF PM 
acetaminophen, diphenhydramine hcl tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
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
ColorBLUE (Light blue) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint Code L437;PM
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
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 finalpart34309/05/200710/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/05/200710/01/2012
Labeler - Amerisource Bergen (007914906)

Revised: 11/2017
 
Amerisource Bergen