NIGHTTIME SEVERE COUGH AND COLD- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride powder, for solution
CARDINAL HEALTH
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.
----------
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 20o -25oC (68o-77oF). 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.