Search by Drug Name or NDC

NDC 00536-1321-97 Rugby Childrens Acetaminophen 160 mg/5mL Details

Rugby Childrens Acetaminophen 160 mg/5mL

Rugby Childrens Acetaminophen is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 00536-1321-97
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	00536-1321
Product ID	0536-1321_304a9aa2-9198-44ca-8627-d41b84ec6cbf
Associated GPIs	64200010001840
GCN Sequence Number	016947
GCN Sequence Number Description	acetaminophen ORAL SUSP 160 MG/5ML ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	26911
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Rugby Childrens Acetaminophen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	SUSPENSION
Route	ORAL
Active Ingredient Strength	160
Active Ingredient Units	mg/5mL
Substance Name	ACETAMINOPHEN
Labeler Name	Rugby Laboratories
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00536-1321-97 (00536132197)

Pricing Information
NDC Package Code	0536-1321-97
Billing NDC	00536132197
Package	1 BOTTLE in 1 CARTON (0536-1321-97) / 118 mL in 1 BOTTLE
Marketing Start Date	2020-10-21
NDC Exclude Flag	N
Price Per Unit	0.01882
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	CHLD ACETAMINOPHEN 160 MG/5 ML
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 304a9aa2-9198-44ca-8627-d41b84ec6cbf Details

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

•: 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
•: if your child has ever had an allergic reaction to this product or any of its ingredients

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 (see overdose warning)

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 right away (1-800-222-1222). 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
•: do not give more than directed (see overdose warning)
•: shake well before using
•: mL = milliliter
•: find right dose on chart below. If possible, use weight to dose; otherwise, use age.
•: remove the child protective cap and squeeze your child’s dose into the dosing cup
•: repeat dose every 4 hours while symptoms last
•: do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL)*
under 24	under 2 years	ask a doctor
24-35	2-3 years	5 mL
36-47	4-5 years	7.5 mL
48-59	6-8 years	10 mL
60-71	9-10 years	12.5 mL
72-95	11 years	15 mL

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

•: each 5 mL contains: sodium 3 mg
•: store at 20-25°C (68-77°F)
•: do not use if printed neckband is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

Questions or comments?

1-800-645-2158

Principal Display Panel

Compare to the active ingredient in Children’s Tylenol® Oral Suspension

Children’s

Acetaminophen

160 mg per 5 mL

Oral Suspension

Pain Reliever/Fever Reducer

Fast, effective relief of children’s pain and fever

Ibuprofen Free

Alcohol Free

Aspirin Free

Grape Flavor

For Ages 2 to 11 Years

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

RUGBY CHILDRENS ACETAMINOPHEN

acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1321
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)
CARRAGEENAN (UNII: 5C69YCD2YJ)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)

Product Characteristics
Color	PURPLE (viscous)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0536-1321-97	1 in 1 CARTON	10/21/2020
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	10/21/2020

Labeler - Rugby Laboratories (079246066)

Revised: 10/2020

Document Id: 304a9aa2-9198-44ca-8627-d41b84ec6cbf

Set id: 304a9aa2-9198-44ca-8627-d41b84ec6cbf

Version: 1

Effective Time: 20201021