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

Extra Strength Night Time Pain Relief by

Drug Labeling and Warnings

Extra Strength Night Time Pain Relief by is a Otc medication manufactured, distributed, or labeled by AMERISOURCE BERGEN, Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-707
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	P525
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-707-78	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2022
2	NDC: 46122-707-71	1 in 1 CARTON	09/16/2022
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 46122-707-62	1 in 1 CARTON	10/05/2022
3		24 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 Drug	M013	06/01/2022	02/28/2026

Labeler - AMERISOURCE BERGEN (007914906)

Registrant - Geri-Care Pharmaceutical Corp (611196254)