Nortemp Infants Drops

Manufacturer: Ballay Pharmaceuticals, Inc
Effective date: 2013-12-20
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-05-31 22:37:53

Label at a glance#

ProductNortemp

Active ingredientAcetaminophen

Label structure12 sections

Indications and uses

temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headaches ■ sore throat ■ toothaches

Dosage and administration

■ this product does not contain directions or complete warnings for adult use ■ do not give more than directed (see overdose warning) ■ find right dose chart, if possible use weight to dose; otherwise, use age ■ use only enclosed dropper designed for use with this product, do not use any other dosing device ■ fill to dose level ■dispense liquid slowly into child's mouth, toward inner cheek ■ may be given alone or ...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-847-1921

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)

OTC - PURPOSE SECTION

Purpose: Fever reducer/pain reliever

Uses

INDICATIONS & USAGE SECTION

temporarily:

■ reduces fever

■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headaches ■ sore throat ■ toothaches

Warnings

WARNINGS SECTION

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

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 nonprescription). 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.

Ask a doctor or pharmacist before use if your 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 for more than 5 days
■ fever gets worse or lasts for more than 3 days. These could be signs of serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 (1-800-222-1222) . Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

Weight (lb)	Age (yr)	Dose (mL)
Under 24	under 2 years	Ask a Doctor
24-35	2-3 years	1.6 mL (0.8mL +0.8mL)

For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb

Other information
Store between 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water.

Comments

OTC - QUESTIONS SECTION

1-800-847-1921

Manufactured for:

BallayPharmaceuticals, Inc.
200 Stillwater St.
Wimberley , TX 78676

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
238159	acetaminophen 500 MG in 5 mL Oral Solution	PSN	12
1101345	acetaminophen 100 MG/ML Oral Solution [Nortemp]	SBD	12
238159	acetaminophen 100 MG/ML Oral Solution	SCD	12
238159	acetaminophen 500 MG per 5 ML Oral Solution	SY	12
238159	acetaminophen 80 MG per 0.8 ML Oral Solution	SY	12
238159	APAP 100 MG/ML Oral Solution	SY	12
1101345	APAP 100 MG/ML Oral Solution [Nortemp]	SY	12
1101345	Nortemp 100 MG/ML Oral Solution	SY	12
1101345	Nortemp 80 MG per 0.8 ML Oral Solution	SY	12

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63162-518-30	2019-11-27	C162847	48780-1	9855e2a2-4e2a-60a7-e053-dbdaa90a05bd	Nortemp Infants Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63162-518-30	Nortemp	30 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	30		12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63162-518	NORTEMP (ACETAMINOPHEN) SOLUTION/ DROPS [BALLAY PHARMACEUTICALS, INC]	12	1 package rows	20131221_9201e74f-1bfa-4fba-af75-3bc6721f2f00.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63162-518-30	ML - Milliliter	63162-518	a48d4f6c-4414-46a8-beae-2f78e428a1c1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	12
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	12
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	12
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	12
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	12
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	12
saccharin sodium dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	12
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	12
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	12
water	INACTIVE INGREDIENT	059QF0KO0R	12

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Nortemp
Acetaminophen
anhydrous citric acid
FD&C yellow no. 6
methylparaben
saccharin sodium dihydrate
sodium benzoate
sodium citrate
propylene glycol
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63162-518	63162-518-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Acetaminophen	362O9ITL9D	ACTIB
anhydrous citric acid	XF417D3PSL	IACT
FD&C yellow no. 6	H77VEI93A8	IACT
methylparaben	A2I8C7HI9T	IACT
saccharin sodium dihydrate	SB8ZUX40TY	IACT
sodium benzoate	OJ245FE5EU	IACT
sodium citrate	1Q73Q2JULR	IACT
propylene glycol	6DC9Q167V3	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 6 · 324 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SUSPENSION / ORAL		85 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	FILM / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / ORAL		43 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EXTENDED RELEASE / ORAL		312 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / PERINEURAL	0.02 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	AEROSOL / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO, SUSPENSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION/ DROPS / ORAL		15 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	GEL / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION / INTRAVENOUS		864 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, DELAYED RELEASE / ORAL	0.02 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	GEL / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	LOTION / TOPICAL		211 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / OPHTHALMIC	0.09 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 34 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
fb610708-d80d-4598-a524-0e8f444d1696			9201e74f-1bfa-4fba-af75-3bc6721f2f00	2013-12-20	Warnings	Exact identifier spl id: fb610708-d80d-4598-a524-0e8f444d1696 spl set id: 9201e74f-1bfa-4fba-af75-3bc6721f2f00

Reported adverse events (FAERS/openFDA)#

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