NIGHTTIME WAL FLU SEVERE COLD AND COUGH- acetaminophen, diphenhydramine, phenylephrine powder, for solution

Nighttime Wal Flu Severe Cold and Cough by

Drug Labeling and Warnings

Nighttime Wal Flu Severe Cold and Cough by is a Otc medication manufactured, distributed, or labeled by WALGREEN CO.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each packet)

Acetaminophen, 650 mg

Diphenhydramine hydrochloride 25 mg

Phenylephrine hydrochloride 10 mg

Purposes

Pain reliever / fever reducer

Antihistamine / Cough Suppressant

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

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

Allergy alert: acetaminophen may cause severe skin reactions, Symptoms may include:

• skin reddening
• blisters
• rash

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 12 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 a 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 a 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
• 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
• taking 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. There could be signs of a serious condition.

If pregnant or breast- feeding,

ask a health 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 at 1-800-222-1222. 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 while symptoms persist, not to exceed 5 packets in 24 hours unless directed by a doctor

• Age:

  Dose

• children 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 6 mg
• store at room temperature. Protect from excessive heat and moisture.

Inactive ingredients

citric acid, FD& C yellow#6, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,

Questions or comments?

1-866-467-2748

Additional Information Listed On Other Panels

Walgreens

Compare to Theraflu® Nighttime Severe Cold &Cough active ingredient††

NIGHTTIME

Wal-Flu® Severe

Cold & Cough

ACETAMINOPHEN/ PAIN RELIEVER/ FEVER REDUCER

DIPHENHYDRAMINE HCl /

ANTIHISTAMINE/ COUGH SUPPRESSANT

PHENYLEPHRINE HCl / NASAL DECONGESTANT

ASPARTAME FREE

SODIUM FREE

• Relieves nasal congestion, cough, body ache, sore throat pain, runny nose, sneezing, headache & fever.

Honey Lemon Flavor Infused with Chamomile & White Tea Flavors

6 PACKETS

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE, KEEP CARTON FOR REFERENCE, DO NOT DISCARD,

TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

Walgreens.com ©2018 Walgreen Co,

WALGREENS PHARMACIST RECOMMENDED‡

‡Walgreens Pharmacist Survey

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu® Nighttime Severe Cold & Cough.

Principal Display

INGREDIENTS AND APPEARANCE

NIGHTTIME WAL FLU SEVERE COLD AND COUGH 
acetaminophen, diphenhydramine, phenylephrine powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-5410
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color		Score
Shape		Size
Flavor	HONEY, LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-5410-06	6 in 1 CARTON; Type 0: Not a Combination Product	05/29/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/29/2018

Labeler - WALGREEN CO. (008965063)