LEADER SEVERE SINUS CONGESTION- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled 
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.

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Cardinal Health Severe Sinus Congestion Drug Facts

Active ingredients (in each capsule)

Acetaminophen 325 mg

Dextromethorphan hydrobromide 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine hydrochloride 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
itching of the nose or throat
itchy, watery eyes
temporarily relieves these symptoms due to a cold:
nasal congestion
sinus congestion and pressure
headache
minor aches and pains
cough
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

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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.
if you have ever had an allergic reaction to this product or any of its ingredients
in children under 12 years of age

Ask a doctor before use if you have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough with excessive phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage
may cause marked drowsiness
avoid alcoholic drinks
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

pain, cough, or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed (see overdose warning)
adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
children under 12 years: do not use

Inactive ingredients

D&C yellow #10, edible ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-800-719-9260

Principal Display Panel

SEE NEW WARNINGS

Compare to Alka-Seltzer Plus® Severe Sinus Congestion active ingredients

Severe Sinus Congestion

Acetaminophen – Pain Reliever / Fever Reducer

Dextromethorphan Hydrobromide – Cough Suppressant

Doxylamine Succinate – Antihistamine

Phenylephrine Hydrochloride – Nasal Decongestant

Allergy & Cough Formula

Sinus Congestion & Pressure

Headache & Pain

Runny Nose & Sneezing

Itchy, Watery Eyes

Cough

Actual Size

20 LIQUID GELS (LIQUID FILLED CAPSULES)

Severe Sinus Congestion Carton
LEADER SEVERE SINUS CONGESTION 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-056
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorGREEN (clear green) Scoreno score
ShapeCAPSULESize20mm
FlavorImprint Code 345
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-056-2010 in 1 CARTON11/21/201302/04/2018
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/21/201302/04/2018
Labeler - Cardinal Health (097537435)

Revised: 12/2018
 
Cardinal Health