Childrens Acetaminophen

Manufacturer: Rij Pharmaceutical Corporation
Effective date: 2018-04-30
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:55:24

Label at a glance#

ProductChildrens Acetaminophen

Active ingredientAcetaminophen

Label structure8 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use. shake well before using find right dose on chart below. If possible, use weight to dose; otherwise, use age. if needed, repeat dose every 4 hours do not give more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor only use enclosed measuring cup Weight (lbs.) Age (yrs.) Dose (tsp or mL) under 24 under 2 ask ...

Storage and handling

• Store at room temperature 15º - 30ºC (59º - 86ºF) • Protect from Freezing. • Protect from Light. • each teaspoon (5 mL) contains: sodium 7 mg • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL = 1 teaspoon)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

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

Warnings

WARNINGS SECTION

Liver warning:

SPL UNCLASSIFIED SECTION

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

Sore throat warning

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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 as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

this product does not contain directions or complete warnings for adult use.
shake well before using
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
if needed, repeat dose every 4 hours
do not give more than 5 times in 24 hours
do not give more than 5 days unless directed by a doctor
only use enclosed measuring cup

Weight (lbs.)	Age (yrs.)	Dose (tsp or mL)
under 24	under 2	ask a doctor
24-35	2-3 years	1 tsp or 5 mL
36-47	4-5 years	1½ tsp or 7.5 mL
48-59	6-8 years	2 tsp or 10 mL
60-71	9-10 years	2½ tsp or 12.5 mL
72-95	11 years	3 tsp or 15 mL

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15º - 30ºC (59º - 86ºF)
Protect from Freezing.
Protect from Light.
each teaspoon (5 mL) contains: sodium 7 mg
TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C red # 40, FD&C blue # 1, flavor, glycerin. PEG 400, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	2
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	2
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	2
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	2
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	2
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	2
307668	APAP 32 MG/ML Oral Suspension	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53807-196-04	2020-01-31	C162847	48780-1	9d75b9d1-00f6-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53807-196-04	Childrens Acetaminophen	118 mL in 1 BOTTLE	ELIXIR	118		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53807-196	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) ELIXIR [RIJ PHARMACEUTICAL CORPORATION]	2	Legacy NDC, 1 package rows	20180502_db5ce69b-0412-41b3-8362-23c1ac852fa8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	1
acetaminophen	ACTIVE MOIETY	362O9ITL9D	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Childrens Acetaminophen
Acetaminophen
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
FD&C BLUE NO. 1
GLYCERIN
POLYETHYLENE GLYCOL 400
SODIUM BENZOATE
SODIUM CITRATE
SACCHARIN SODIUM
SORBITOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53807-196	53807-196-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Acetaminophen	362O9ITL9D	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 377 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / BUCCAL	0.01 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / OPHTHALMIC		46 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SUSPENSION / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SHAMPOO, SUSPENSION / TOPICAL	0.25 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	ELIXIR / ORAL	100 mg/5ml		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii candidate 37 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / OPHTHALMIC	0.03 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	GUM, CHEWING / BUCCAL		48 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAVENOUS		28216 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	AEROSOL, POWDER / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM / SUBLINGUAL	0.07 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / INTRAVENOUS		4050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / TOPICAL		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAVENOUS		33750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	INJECTION / INTRAVENOUS		22 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	EMULSION / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION/ DROPS / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	OINTMENT / TOPICAL		1950 mg	Exact identifier — unii candidate 36 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e6017e01-c08e-46f5-a111-c7b546096805			db5ce69b-0412-41b3-8362-23c1ac852fa8	2018-04-30	Warnings	Exact identifier spl id: e6017e01-c08e-46f5-a111-c7b546096805 spl set id: db5ce69b-0412-41b3-8362-23c1ac852fa8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.