Acetaminophen by Southern Sales & Service, Inc. ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Southern Sales & Service, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each Tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

for the temporary relief of minor aches and pains due to:

Headache

Muscular aches

Backache

Toothache

Premenstrual and menstrual cramps

Temporally reduces fever.

Liver warning Warnings

this product contains Acetaminophen. Severe liver damage may occur if

• adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product

Do not use

• with any other drug containing acetaminophen (prescription or nonprescription) 
• 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 the user has

liver disease

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

Stop use and ask a doctor if

Pain gets worse or lasts more than 10 days in adults.

Pain gets worse or lasts more than 5 days in children under under 12 years

Fever gets worse or last more than 3 days

new symptoms occur

Redness or swelling is present. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a doctor before use.

Keep out of the 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or syptoms.

• Do not take more tahn directed (see overdose warning)

Directions

• Adults and Children 12 years and older:

  Take 2 tablets every 4 to 6 hours while symptoms last

  Do not take more than 12 tablets in 24 hours

• Children 6 to 11 years:

  Take 1 tablet every 4 to 6 hours while symptoms last

  Do not take more than 5 tablets in 24 hours

• Children under 6 years: Do not use regular Strength products in children uder 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

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

Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Acetaminophen 100 tablet

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69822-692(NDC:0536-1327)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	PH020
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69822-692-10	325 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/01/2019

Labeler - Southern Sales & Service, Inc. (013114906)

Registrant - Southern Sales & Service, Inc. (013114906)

Establishment
Name	Address	ID/FEI	Business Operations
Southern Sales & Service, Inc.		013114906	repack(69822-692)