ACETAMINOPHEN by ATLANTIC BIOLOGICALS CORP. / UNIT DOSE SOLUTIONS ACETAMINOPHEN elixir

ACETAMINOPHEN by

Drug Labeling and Warnings

ACETAMINOPHEN by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP., UNIT DOSE SOLUTIONS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

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

• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• toothache
• premenstrual and menstrual cramps.

Temporarily reduces fever.

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

• adult takes more than 6 doses in 24 hours, which is the maximum daily amount
• child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks everyday while using this product.

Sore throat warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has

• liver disease
• is on a sodium-restricted diet.

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

When using this product: Do not exceed recommended dose

Stop use and ask a doctor if:

• Pain gets worse or lasts more than 5 days
• fever gets worse or lasts 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 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. Quick medical
attention is critical for adults/children even if you do not notice any signs or symptoms.

Directions

• shake well before using
• find the right dose on chart below, if possible, use weight to dose; otherwise use age
• dosage may be repeated every 4 hours, or as directed by your doctor
• do not use more than 5 doses in 24 hours
• do not use more than 5 days unless directed by a doctor.
• find right dose on chart below, If possible, use weight to dose; otherwise, use age.

Weight (lbs.)	Age (years)	dosage-teaspoonful (tsp.)
under 24	under 2	consult Physician
24 to 35	2 to 3	1 tsp. (5 mL)
36 to 47	4 to 5	1 1/2 tsp. (7.5 mL)
48 to 59	6 to 8	2 tsp. (10 mL)
60 to 71	9 to 10	2 1/2 tsp. (12.5 mL)
72 to 95	11	3 tsp. (15 mL)

Other information

• Store at room temperature 15°-30° C (59°-86°F)
• Protect from Freezing. 
• Protect from Light.

SPL UNCLASSIFIED SECTION

Inactive Ingredients:

Bubble Gum Flavor, Citric Acid, FD C RED #40, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen elixir

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0179(NDC:71399-0160)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-0179-3	5 in 1 SYRINGE	11/03/2022
1	NDC: 17856-0179-1	48 in 1 BOX, UNIT-DOSE
1	NDC: 17856-0179-2	5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 17856-0179-6	5 in 1 SYRINGE	11/03/2022
2	NDC: 17856-0179-4	48 in 1 BOX, UNIT-DOSE
2	NDC: 17856-0179-5	7.5 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 17856-0179-9	5 in 1 SYRINGE	11/03/2022
3	NDC: 17856-0179-7	120 in 1 BOX, UNIT-DOSE
3	NDC: 17856-0179-8	1.25 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/18/2021

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
UNIT DOSE SOLUTIONS		360804194	repack(17856-0179)