ACETAMINOPHEN PM EXTRA STRENGTH- acetaminophen, diphenhydramine hcl tablet

Acetaminophen PM by

Drug Labeling and Warnings

Acetaminophen PM by is a Otc medication manufactured, distributed, or labeled by FOODHOLD U.S.A., LLC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each gelcap)

Acetaminophen 500 mg
Diphenhydramine HCl 25 mg

Purpose

Pain Reliever 
Nighttime sleep-aid

Uses

temporary relief of 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
• 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 product containing diphenhydramine, even one used on skin
• in children under 12 years of age 
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not
  sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis 
• liver disease 
• difficulty in urination due to enlargement of the prostate gland
• glaucoma

Ask a doctor or pharmacist before use if you are

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

When using this product

• drowsiness will occur
• avoid alcoholic beverages
• 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 a serious underlying medical illness.
• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 10 days 
• fever gets worse or lasts more than 3 days 

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
• adults and children 12 years and over
  • take 2 gelcaps at bedtime
  • do not take more than 2 gelcaps of this product in 24 hours
    

• children under 12 years: do not use 

Other information

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• avoid high humidity
• see end flap for expiration date and lot number 

Inactive ingredients

ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C red #3, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

Careone®

NDC: 41520-956-31

Compare to the active ingredients in Extra Strength Tylenol® PM*

Extra Strength 
Acetaminophen PM

Acetaminophen, 500 mg 
Diphenhydramine HCl, 25 mg 

Pain Reliever 
Nighttime Sleep Aid

Non-habit forming
Rapid Release

80 GELCAPS 

Actual Size 

OUR PHARMACISTS
Rx
RECOMMEND

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

*This Product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Extra Strength Tylenol® PM.

50844    ORG041755631

DISTRIBUTED BY
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
1-877-846-9949 ©2018 S&S Brands, LLC
Quality guaranteed or your money back.

Care one 44-556

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN PM  EXTRA STRENGTH
acetaminophen, diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-956
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
GELATIN (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
AMMONIA (UNII: 5138Q19F1X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	BLUE (dark blue) , BLUE (light blue)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	L;6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-956-09	1 in 1 CARTON	12/17/2007
1		20 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 41520-956-31	1 in 1 CARTON	12/17/2007
2		80 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 NOT FINAL	part343	12/17/2007

Labeler - FOODHOLD U.S.A., LLC (809183973)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(41520-956)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(41520-956)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(41520-956)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	MANUFACTURE(41520-956) , PACK(41520-956)