ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG- acetaminophen / diphenhydramine tablet

ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG by

Drug Labeling and Warnings

ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG by is a Otc medication manufactured, distributed, or labeled by Reliable 1 Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Acetaminophen 500 mg

Diphenhydramine HCL 25 mg

PURPOSE

Pain reliever

Nighttime sleep aid

INDICATIONS & USAGE

temporarily relieves occasional headaches and minor aches and pains 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 which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

OTHER SAFETY INFORMATION

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

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription). If ypu are not sure whether a drug contains acetaminophen, ask doctor or pharmacist.
• with any other drug containing diphenhydramine, even one used on skin
• in children under 12 years of age

ASK DOCTOR

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

Drug Facts continued on back of label

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

WHEN USING

When using this product

• marked drowsiness will occur
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase droqsiness
• do not drive a motor vehicle or operate machinery

STOP USE

Stop use and ask a doctor if

• sleeplessness lasts for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• redness or swelling is present
• new symptoms occur

These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Incase of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice 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 if needed
• do not take more than directed

children under 12 years: do not use

Other information

store at room temperature 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT

croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, pregelatinized corn starch, silicon dioxide, stearic acid, titanium dioxide

QUESTIONS

call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol® PM

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

PRINCIPAL DISPLAY PANEL

NDC: 69618-013-05

Acetaminophen 500 mg & Diphenhydramine HCL 25 mg

PAIN RELIEVER

NIGHTTIME SLEEP AID

50 CAPLETS

*Compare to Active Ingredients in Tylenol® PM

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN / DIPHENHYDRAMINE 500/25 MG 
acetaminophen / diphenhydramine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69618-013
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue (Light Blue)	Score	no score
Shape	OVAL	Size	7mm
Flavor		Imprint Code	AP;133
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69618-013-05	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/01/2015

Labeler - Reliable 1 Laboratories LLC (079718111)