Label: ACETAMINOPHEN elixir
- NDC Code(s): 17856-5403-1, 17856-5403-2, 17856-5403-3, 17856-5403-4
- Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 71399-0161
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated September 2, 2020
If you are a consumer or patient please visit this version.
- Active ingredient (in each 5 mL = 1 teaspoonful)
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 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.
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.
- 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.
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
3 tsp. (15 mL)
- Other information
Grape Flavor, Citric Acid, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol Solution 70% & Sodium Benzoate.
17856-5403-01 ACETAMINOPHEN - 2.5 ML SYRINGE 120 ct UD
17856-5403-02 ACETAMINOPHEN - 15.6 ML CUP 50 ct UD
17856-5403-03 ACETAMINOPHEN - 1.25 ML SYRINGE 120 ct UD
17856-5403-04 ACETAMINOPHEN - 3.75 ML CUP 72 ct UD
Questions or Comments?
Call (877) 225-6999 Monday - Friday 9AM-5PM EST
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
ATLANTIC BIOLOGICALS CORP.
MIAMI, FL 33179
- Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-5403(NDC:71399-0161) 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 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 Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-5403-1 120 in 1 BOX, UNIT-DOSE 09/02/2020 1 2.5 mL in 1 SYRINGE; Type 0: Not a Combination Product 2 NDC:17856-5403-3 120 in 1 BOX, UNIT-DOSE 09/02/2020 2 1.25 mL in 1 SYRINGE; Type 0: Not a Combination Product 3 NDC:17856-5403-2 50 in 1 BOX, UNIT-DOSE 09/02/2020 3 15.6 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 4 NDC:17856-5403-4 72 in 1 BOX, UNIT-DOSE 09/02/2020 4 3.75 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 07/28/2020 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 relabel(17856-5403) , repack(17856-5403)