Childrens Pain Relief

Manufacturer: Chain Drug Consortium (Premier Value) | davAgen Pharmaceutical, LLC
Effective date: 2014-10-28
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:40:47

Label at a glance#

ProductChildrens Pain Relief

Active ingredientAcetaminophen

Label structure11 sections

Indications and uses

temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat 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. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device tsp = teaspoon, mL = milliliter if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours d...

Storage and handling

store at controlled room temperature dosage cup provided each teaspoon contains: sodium 2 mg

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-732-249-6363

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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
- 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

SPL UNCLASSIFIED SECTION

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

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 the child is taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage (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 for more than 3 days. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

Overdose Warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose (overdose) could cause serious health problems including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical 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.
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device
tsp = teaspoon, mL = milliliter
if needed, repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
do not give more than 5 days unless directed by a doctor

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

Other information

STORAGE AND HANDLING SECTION

store at controlled room temperature
dosage cup provided
each teaspoon contains: sodium 2 mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose, D & C Red # 33, FD & C Red # 40, Flavors, Glycerin, High Fructose Corn Syrup, Methylparaben, Microcrystalline Cellulose, Polyethylene Glycol 1450, Propylene Glycol, Propylparaben, Purified Water, Saccharin Sodium, Sorbitol Solution, Sucralose Powder, Xanthan Gum

Questions or comments?

OTC - QUESTIONS SECTION

1-732-249-6363

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68016-178-04

Premier
Value ^®

Children's
Pain Relief
PAIN RELIEVER - FEVER REDUCER
ACETAMINOPHEN
SUSPENSION LIQUID

• Alcohol Free
• Aspirin Free
• Ibuprofen Free

Bubble
Gum
Flavor

4 FL OZ (118 mL)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

Principal Display Panel - 118 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	1
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	1
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	1
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	1
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	1
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	1
307668	APAP 32 MG/ML Oral Suspension	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68016-178-04	2020-01-31	C162847	48780-1	9d75b9d1-162f-f424-e053-dadaa90a57ce	Children's Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-178-04	Childrens Pain Relief	1 in 1 CARTON	LIQUID	1		1
68016-178-04	Childrens Pain Relief	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-178	CHILDRENS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]	1	Legacy NDC, 2 package rows	20141112_79d06662-1677-4032-bf55-314af0f68d15.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-178-04	ML - Milliliter	68016-178	6c942538-8b88-4b75-a1db-412ea384f2f3	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	1
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	1
Carboxymethylcellulose	INACTIVE INGREDIENT	05JZI7B19X	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	1
D&C Red No. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
High Fructose Corn Syrup	INACTIVE INGREDIENT	XY6UN3QB6S	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
Polyethylene Glycol 1450	INACTIVE INGREDIENT	OJ4Z5Z32L4	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1
Sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Childrens Pain Relief
Acetaminophen
Xanthan Gum
Carboxymethylcellulose
Cellulose, Microcrystalline
Methylparaben
Propylparaben
Sucralose
Saccharin Sodium
Propylene Glycol
Polyethylene Glycol 1450
High Fructose Corn Syrup
Glycerin
Sorbitol
D&C Red No. 33
FD&C Red No. 40
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68016-178	68016-178-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Acetaminophen	362O9ITL9D	ACTIB
Xanthan Gum	TTV12P4NEE	IACT
Carboxymethylcellulose	05JZI7B19X	IACT
Cellulose, Microcrystalline	OP1R32D61U	IACT
Methylparaben	A2I8C7HI9T	IACT
Propylparaben	Z8IX2SC1OH	IACT
Sucralose	96K6UQ3ZD4	IACT
Saccharin Sodium	SB8ZUX40TY	IACT
Propylene Glycol	6DC9Q167V3	IACT
Polyethylene Glycol 1450	OJ4Z5Z32L4	IACT
High Fructose Corn Syrup	XY6UN3QB6S	IACT
Glycerin	PDC6A3C0OX	IACT
Sorbitol	506T60A25R	IACT
D&C Red No. 33	9DBA0SBB0L	IACT
FD&C Red No. 40	WZB9127XOA	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 9 · 521 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 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 Red No. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRALESIONAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 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
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
D&C Red No. 33	D&C RED NO. 33	9DBA0SBB0L	CONCENTRATE / ORAL	0.02 mg/1ml		Exact identifier — unii candidate 14 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C Red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, EXTENDED RELEASE / ORAL	2.22 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Cellulose, Microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TROCHE / ORAL		300 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	SUSPENSION / ORAL		383 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / BUCCAL		5110 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 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
fb03bf24-dbff-419e-82c7-04e1917b5208			79d06662-1677-4032-bf55-314af0f68d15	2014-10-28	Warnings	Exact identifier spl id: fb03bf24-dbff-419e-82c7-04e1917b5208 spl set id: 79d06662-1677-4032-bf55-314af0f68d15

Reported adverse events (FAERS/openFDA)#

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