FDA Label for Nighttime Severe Cough And Cold

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

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 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
• •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. 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; not to exceed 5 packets in 24 hours or as 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 6 mg
• •store at controlled room temperature 20^o -25^oC (68^o-77^oF). Protect from excessive heat and moisture.

Inactive Ingredients

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

Questions Or Comments?

1-866-467-2748

Additional Information Listed On Other Panels

LEADER

NDC 70000-0128-1

Nighttime Severe Cold &Cough

Acetaminophen

Diphenhydramine HCl

Phenylephrine HCl

Pain reliever/ Fever reducer

Antihistamine/ Cough suppressant

Nasal Decongestant

Honey Lemon

Infused with Chamomile & White Tea Flavors

Naturally and Artificially Flavored

COMPARE TO THERAFLU^® NIGHTTIME SEVERE COLD & COUGH* active ingredients *

100% Money Back Guarantee

Relieves:

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

6 PACKETS

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

NIGHTTIME Severe Cough & Cold

Cardinal Health™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to care™ since 1979

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

©2017 CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu^® Nighttime Severe Cold & Cough.