EXTRA STRENGTH NIGHT TIME PAIN MEDICINE- acetaminophen, diphenhydramine hcl tablet

Extra Strength Night Time Pain Medicine by

Drug Labeling and Warnings

Extra Strength Night Time Pain Medicine by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceutical Corp, Allegiant Health. 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 directed 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

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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults / children even if you do not notice any signs / symptoms.

Directions

do not exceed recommended dose

• Adults and Children 12 years and over: Take 2 caplets at bedtime if needed, or as directed by a doctor.
• Children under 12 years: Do not use.

Other information

Tamper Evident: do not use if imprinted safety seal under cap is broken or missing.

store at room temperature

Inactive ingredients

cellulose, croscarmellose sodium, FD and C blue no.1, hypromellose, PEG, stearic acid, titanium dioxide. May also contain silica, sodium starch glycolate.

package Label

57896-224-05

Health star the sensible choice for price and health

Extra Strength

pain relief and sleep aid

night time pain medicine

acetaminophen 500 mg

Diphenhydramine HCl 25mg

100 caplets

compare to the active ingredients in tylenol pm

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH NIGHT TIME PAIN MEDICINE 
acetaminophen, diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-224
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE (caplet)	Size	18mm
Flavor		Imprint Code	AZ267
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-224-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2012
2	NDC: 57896-224-05	50 in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/1996

Labeler - Geri-Care Pharmaceutical Corp (611196254)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Establishment
Name	Address	ID/FEI	Business Operations
Allegiant Health		079501930	manufacture(57896-224)