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NDC 17856-0179-03 ACETAMINOPHEN 160 mg/5mL Details

ACETAMINOPHEN 160 mg/5mL

ACETAMINOPHEN is a ORAL ELIXIR in the HUMAN OTC DRUG category. It is labeled and distributed by ATLANTIC BIOLOGICALS CORP.. The primary component is ACETAMINOPHEN.

Product Information

NDC	17856-0179
Product ID	17856-0179_b9868329-402b-438b-b80c-eeee223fe3af
Associated GPIs
GCN Sequence Number	004481
GCN Sequence Number Description	acetaminophen ELIXIR 160 MG/5ML ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16913
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	ACETAMINOPHEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	ELIXIR
Route	ORAL
Active Ingredient Strength	160
Active Ingredient Units	mg/5mL
Substance Name	ACETAMINOPHEN
Labeler Name	ATLANTIC BIOLOGICALS CORP.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2023-12-31

Package

Package Images

NDC 17856-0179-03 (17856017903)

Pricing Information	N/A
NDC Package Code	17856-0179-3
Billing NDC	17856017903
Package	5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0179-3) / 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0179-1) / 5 mL in 1 SYRINGE (17856-0179-2)
Marketing Start Date	2022-11-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aa1c0232-c806-4674-9ac3-6cae7f7499b4 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	05/18/2021

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

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

Revised: 10/2022

Document Id: b9868329-402b-438b-b80c-eeee223fe3af

Set id: aa1c0232-c806-4674-9ac3-6cae7f7499b4

Version: 1

Effective Time: 20221025