Nighttime by Taro Pharmaceuticals U.S.A. Inc. / Taro Pharmaceutical Industries Ltd. Nighttime Flu and Severe

Nighttime by

Drug Labeling and Warnings

Nighttime by is a Otc medication manufactured, distributed, or labeled by Taro Pharmaceuticals U.S.A. Inc., Taro Pharmaceutical Industries Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NIGHTTIME  FLU AND SEVERE- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution 
Taro Pharmaceuticals U.S.A. Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Nighttime
Flu and Severe

Drug Facts

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

• 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

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.

Liver warning

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

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

• 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

• 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

Ask a doctor or pharmacist before use if you are taking

• sedatives or tranquilizers
• the blood thinning drug warfarin

When using this product

• 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

• 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.

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

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

• 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

• 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

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?

Call 1-866-923-4914

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

PRINCIPAL DISPLAY PANEL - 6 Packet Carton

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

NIGHTTIME   FLU AND SEVERE
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51672-2113
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	650 mg
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	25 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	10 mg

Inactive Ingredients
Ingredient Name	Strength
acesulfame potassium (UNII: 23OV73Q5G9)
aspartame (UNII: Z0H242BBR1)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C yellow no. 10 (UNII: 35SW5USQ3G)
FD&C blue No. 1 (UNII: H3R47K3TBD)
FD&C red no. 40 (UNII: WZB9127XOA)
maltodextrin (UNII: 7CVR7L4A2D)
anhydrous trisodium citrate (UNII: RS7A450LGA)
sucrose (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-2113-7	6 in 1 CARTON; Type 0: Not a Combination Product	06/28/2013	01/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/28/2013	01/17/2020

Labeler - Taro Pharmaceuticals U.S.A. Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceutical Industries Ltd.		600072078	MANUFACTURE(51672-2113)

Revised: 1/2020

Document Id: 051fc467-fc4d-431b-a21e-03a4d01b786d

34390-5

Set id: 4bc5a105-aed4-4c62-a389-c17678cd5d77

Version: 3

Effective Time: 20200130