EXTRA STRENGTH NIGHT TIME PAIN RELIEF- acetaminophen, diphenhydramine hcl tablet, coated 
AMERISOURCE BERGEN

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GNP 224B (324)

Active Ingredients

Acetaminophen 500 mg

Diphenhydramine HCI 25 mg

Purposes

Pain Reliever

Sleep aid

Uses

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

Warnings

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

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include: • skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.

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

Ask a doctor or pharmacist before use if you are taking • the blood thinning drug warfarin

• sedatives or tranquilizers

When using this product • drowsiness will occur • do not drive a motor vehicle or operate machinery after use • avoid alcoholic drinks

Stop use and ask a doctor if • 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 that 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present.These may 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:
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

• do not take more than directed (see overdose 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

Other information

• store at controlled room temperature 20-25 °C (68-77° F)

Inactive ingredients

cellulose, croscarmellose sodium, FD&C blue #1 lake,
FD&C blue #2 lake, hypromellose, magnesium
stearate, PEG, polyvinyl alcohol, povidone,
purified water, silicon dioxide, sodium starch
glycolate, starch, talc, titanium dioxide

Questions or comments?

1-800-540-3765

package Label

1

EXTRA STRENGTH NIGHT TIME PAIN RELIEF 
acetaminophen, diphenhydramine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-707
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
TALC (UNII: 7SEV7J4R1U)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POVIDONE (UNII: FZ989GH94E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
WATER (UNII: 059QF0KO0R)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize18mm
FlavorImprint Code P525
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-707-78100 in 1 BOTTLE; Type 0: Not a Combination Product09/20/2022
2NDC:46122-707-711 in 1 CARTON09/16/2022
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:46122-707-621 in 1 CARTON10/05/2022
324 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/01/2022
Labeler - AMERISOURCE BERGEN (007914906)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 10/2023
Document Id: 081540c1-317b-7873-e063-6394a90a0738
Set id: e5f93e73-9e1e-150a-e053-2995a90a2778
Version: 3
Effective Time: 20231019
 
AMERISOURCE BERGEN