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)

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

trmporarily:

• reduces fever
• relieves minor aches and pains due to:
• the common cold
• flu
• headache
• sore throat
• toothache

Warnings

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if your child takes:

• more than 5 doses in 24 hours, which is the maximum daily amount 
• with other drugs containing acetaminophen.

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.

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

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.

Keep out of reach of children.

Overdose Warning:

In case of overdose get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical
attention is critical even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use
• shake well before using
• mL=milliliter
• find the right dose on chart below, if possible, use weight to dose; otherwise use age
• use only the enclosed dosing cup designed for use with this product.
• Do not use any other dosing device. 
• if needed, repeat dose every 4 hours while symptoms last 
• do not give more than 5 times in 24 hours 
• do not give more than 5 days unless directed by doctor.

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

Other information

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

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Inactive Ingredients:

bubble gum flavor, citric acid, glycerin, polyethylene glycol 400, purified water, sodium citrate, saccharin sodium, sorbitol solution & sodium benzoate.

Questions or Comments?

Call (877) 225-6999 Monday - Friday 9AM-5PM EST

DISTRIBUITED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Elixir

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen elixir

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-0166(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: 17856-0166-1	72 in 1 BOX, UNIT-DOSE	03/13/2023
1	NDC: 17856-0166-2	10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 17856-0166-3	50 in 1 BOX, UNIT-DOSE	03/13/2023
2	NDC: 17856-0166-4	20.31 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3	NDC: 17856-0166-7	50 in 1 BOX, UNIT-DOSE	03/13/2023
3	NDC: 17856-0166-8	31.2 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
4	NDC: 17856-0166-5	72 in 1 BOX, UNIT-DOSE	03/13/2023
4	NDC: 17856-0166-6	15 mL in 1 CUP, UNIT-DOSE; 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	05/18/2021

Labeler - ATLANTIC BIOLOGICALS CORP (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
UNIT DOSE SOLUTIONS		360804194	repack(17856-0166)