ACETAMINOPHEN- acetaminophen elixir 
ATLANTIC BIOLOGICALS CORP.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Children’s Pain Relief
Grape Flavor
Pain Reliever and Fever Reducer

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.

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

Inactive Ingredients:

Grape Flavor, Citric Acid, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.

How Supplied:

17856-5401-01 ACETAMINOPHEN - 48MG/1.5ML SYRINGE 120 UD
17856-5401-02 ACETAMINOPHEN - 64MG/2ML SYRINGE 120 UD
17856-5401-03 ACETAMINOPHEN - 96MG/3ML SYIRNGE 120 UD
17856-5401-04 ACETAMINOPHEN - 3.75 ML SYRINGE 48 ct UD
17856-5401-05 ACETAMINOPHEN - 5 ML CUP 72 ct UD
17856-5401-06 ACETAMINOPHEN - 192MG/6ML SYRINGE 48 ct UD
17856-5401-07 ACETAMINOPHEN - 240MG/7.5ML SYRINGE 48 ct UD
17856-5401-08 ACETAMINOPHEN - 325MG/10.15 ML CUP 72 ct UD
17856-5401-09 ACETAMINOPHEN - 480MG/15ML 50 CUP ct UD

Questions or Comments?

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

Manufactured for
Akron Pharma, Inc.,
Fairfeld, NJ - 07004

Manufactured In USA

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

Distributed by:

ATLANTIC BIOLOGICALS CORP.

Miami, FL 33179

Principal Display Panel

• Compare To Active ingredient of Children's Tylenol Elixir

Children's

Pain Relief

Pain Reliever and
Fever Reducer

Acetaminophen 160 mg per 5 ml Oral Elixir

• Alcohol Free

• Asprin Free

• For Ages 2 - 11 years

Grape Flavor

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ACETAMINOPHEN 
acetaminophen elixir
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-5401(NDC:71399-0161)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
GRAPE (UNII: 6X543N684K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-5401-1120 in 1 BOX, UNIT-DOSE09/02/2020
11.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
2NDC:17856-5401-2120 in 1 BOX, UNIT-DOSE09/02/2020
22 mL in 1 SYRINGE; Type 0: Not a Combination Product
3NDC:17856-5401-3120 in 1 BOX, UNIT-DOSE09/02/2020
33 mL in 1 SYRINGE; Type 0: Not a Combination Product
4NDC:17856-5401-448 in 1 BOX, UNIT-DOSE09/02/2020
43.75 mL in 1 SYRINGE; Type 0: Not a Combination Product
5NDC:17856-5401-572 in 1 BOX, UNIT-DOSE09/02/2020
55 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
6NDC:17856-5401-648 in 1 BOX, UNIT-DOSE09/02/2020
66 mL in 1 SYRINGE; Type 0: Not a Combination Product
7NDC:17856-5401-748 in 1 BOX, UNIT-DOSE09/02/2020
77.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
8NDC:17856-5401-872 in 1 BOX, UNIT-DOSE09/02/2020
810.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
9NDC:17856-5401-950 in 1 BOX, UNIT-DOSE09/02/2020
915 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/28/2020
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-5401) , repack(17856-5401)

Revised: 9/2020
Document Id: b17d8b01-e4bf-4730-b154-c7c0d363e95a
Set id: e040616b-bdca-4f5d-9d43-6dc64dc425f1
Version: 1
Effective Time: 20200902
 
ATLANTIC BIOLOGICALS CORP.