Nighttime

Manufacturer: Taro Pharmaceuticals U.S.A. Inc. | Taro Pharmaceutical Industries Ltd.
Effective date: 2015-06-09
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:31:39

Label at a glance#

ProductNighttime Flu and Severe

Active ingredientAcetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage and administration

do not use more than directed take every 4 hours; do not take more than 5 packets in 24 hours unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. if...

Storage and handling

each packet contains: potassium 4 mg, sodium 27 mg phenylketonurics: contains phenylalanine 34 mg per packet store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.

Contacts and useful links#

PhoneLabel contact1-866-923-4914

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each packet)	Purposes
Acetaminophen 650 mg	Pain reliever/fever reducer
Diphenhydramine hydrochloride 25 mg	Antihistamine/cough suppressant
Phenylephrine hydrochloride 10 mg	Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- nasal and sinus congestion
- runny nose
- sneezing
- itchy nose or throat
- itchy, watery eyes due to hay fever
- cough due to minor throat and bronchial irritation
temporarily reduces fever

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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.

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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

in a child under 4 years of age
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
with any other product containing diphenhydramine, even one used on the skin
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
a sodium-restricted diet
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema, asthma or chronic bronchitis
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking

sedatives or tranquilizers
the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage
avoid alcoholic drinks
marked drowsiness may occur
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

nervousness, dizziness, or sleeplessness occurs
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
symptoms do not get better or worsen
pain, cough or nasal congestion gets worse or lasts more than 7 days
cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a heath care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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

do not use more than directed
take every 4 hours; do not take more than 5 packets in 24 hours unless directed by a doctor

Age	Dose
children under 4 years of age	do not use
children 4 to under 12 years of age	do not use unless directed by a doctor
adults and children 12 years of age and over	one packet

dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.

Other information

STORAGE AND HANDLING SECTION

each packet contains: potassium 4 mg, sodium 27 mg
phenylketonurics: contains phenylalanine 34 mg per packet
store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, aspartame, citric acid anhydrous, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, sodium citrate anhydrous, sucrose, and pregelatinized starch.

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51672-2113-7

Compare to the active
ingredients in Theraflu^®
Nighttime Severe Cold & Cough*

See New Warnings
Information & Directions

Nighttime

Flu & Severe
Cold & Cough

Acetaminophen - Pain reliever/fever reducer
Diphenhydramine HCl - Antihistamine/cough suppressant
Phenylephrine HCl - Nasal decongestant

Nasal Congestion
Sore Throat Pain
Cough
Headache
Body Ache
Fever
Runny Nose
Sneezing

Honey Lemon
Infused with
Chamomile & White Tea Flavors

6 Packets

Principal Display Panel - 6 Packet Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	2
Diphenhydramine Hydrochloride	ACTIVE INGREDIENT	TC2D6JAD40	2
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	2
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	2
Diphenhydramine	ACTIVE MOIETY	8GTS82S83M	2
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	2
acesulfame potassium	INACTIVE INGREDIENT	23OV73Q5G9	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	2
anhydrous trisodium citrate	INACTIVE INGREDIENT	RS7A450LGA	2
aspartame	INACTIVE INGREDIENT	Z0H242BBR1	2
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	2
FD&C blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	2
maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	2
sucrose	INACTIVE INGREDIENT	C151H8M554	2

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Nighttime Flu and Severe
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
Acetaminophen
Diphenhydramine Hydrochloride
Diphenhydramine
Phenylephrine Hydrochloride
Phenylephrine
acesulfame potassium
aspartame
ANHYDROUS CITRIC ACID
D&C yellow no. 10
FD&C blue No. 1
FD&C red no. 40
maltodextrin
anhydrous trisodium citrate
sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51672-2113	51672-2113-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Acetaminophen	362O9ITL9D	ACTIB
Diphenhydramine Hydrochloride	TC2D6JAD40	ACTIB
Phenylephrine Hydrochloride	04JA59TNSJ	ACTIB
acesulfame potassium	23OV73Q5G9	IACT
aspartame	Z0H242BBR1	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
D&C yellow no. 10	35SW5USQ3G	IACT
FD&C blue No. 1	H3R47K3TBD	IACT
FD&C red no. 40	WZB9127XOA	IACT
maltodextrin	7CVR7L4A2D	IACT
anhydrous trisodium citrate	RS7A450LGA	IACT
sucrose	C151H8M554	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 5 · 286 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.02 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
anhydrous trisodium citrate	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	INJECTION / INTRABURSAL	1 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
anhydrous trisodium citrate	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	TABLET / SUBLINGUAL		36 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
aspartame	ASPARTAME	Z0H242BBR1	GRANULE, FOR SUSPENSION / ORAL		420 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	SUSPENSION / ORAL		6040 mg	Exact identifier — unii candidate 15 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
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / SUBCUTANEOUS		101 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous trisodium citrate	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	INJECTION / INTRAMUSCULAR		792 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER, FOR SUSPENSION / ORAL		76 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, ORALLY DISINTEGRATING / ORAL		46 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous trisodium citrate	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	FILM / SUBLINGUAL		4 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	POWDER, FOR SOLUTION / ORAL	117 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, EXTENDED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE / ORAL		131 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous trisodium citrate	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR		240 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, FILM COATED / ORAL	1.75 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
anhydrous trisodium citrate	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	LOTION / TOPICAL	0.08 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
aspartame	ASPARTAME	Z0H242BBR1	POWDER / ORAL		63 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
FD&C blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL		111 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
anhydrous trisodium citrate	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	CREAM / TOPICAL		4 mg	Exact identifier — unii candidate 30 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
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM / BUCCAL		9 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INTRACARDIAC		25 mg	Exact identifier — unii candidate 61 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
sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
anhydrous trisodium citrate	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	INJECTION / INTRALESIONAL		22 mg	Exact identifier — unii candidate 30 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
FD&C blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	ELIXIR / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	GUM, CHEWING / BUCCAL		24 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
anhydrous trisodium citrate	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	INJECTION / INTRAVENOUS		792 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
aspartame	ASPARTAME	Z0H242BBR1	LOZENGE / ORAL		136 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, SOLUTION / INTRAVENOUS		772 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / BUCCAL		30 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / ORAL		3900 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
FD&C blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 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
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, COATED / ORAL	2.5 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, ORALLY DISINTEGRATING / ORAL		24 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INTRAVENOUS		1152 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	SHAMPOO / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C red no. 40	FD&C RED NO. 40	WZB9127XOA	SHAMPOO / TOPICAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	SOLUTION / ORAL		1451 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
anhydrous trisodium citrate	ANHYDROUS TRISODIUM CITRATE	RS7A450LGA	SOLUTION / ORAL		240 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE, LIQUID FILLED / ORAL		360 mg	Exact identifier — unii candidate 61 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
d95641a2-6c74-4fdf-bdac-77773a41f921			4bc5a105-aed4-4c62-a389-c17678cd5d77	2015-06-09	Warnings	Exact identifier spl id: d95641a2-6c74-4fdf-bdac-77773a41f921 spl set id: 4bc5a105-aed4-4c62-a389-c17678cd5d77

Reported adverse events (FAERS/openFDA)#

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