Severe Allergy And Sinus Headache Maximum Strength

Medically reviewed by Drugs.com. Last updated on Oct 19, 2021.

Dosage form: tablet, film coated
Ingredients: ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: CVS Pharmacy
NDC Code: 59779-543

CVS 44-543

Active ingredients (in each caplet)

Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever
Antihistamine
Nasal decongestant

Uses

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

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.
with any other product containing diphenhydramine, even one used on 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.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

glaucoma
heart disease
high blood pressure
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis
liver disease
thyroid disease
diabetes

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
excitability may occur, especially in children
marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery
avoid alcoholic beverages

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
pain 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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 take more than directed
adults and children 12 years and over
- take 2 caplets every 4 hours
- do not take more than 10 caplets in 24 hours
children under 12 years: ask a doctor

Other information

see end flap for expiration date and lot number
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

Questions or comments?

1-800-426-9391

Principal Display Panel

♥ CVS Health™

Caplets

MAXIMUM STRENGTH
Severe Allergy
& Sinus Headache
ACETAMINOPHEN, DIPHENHYDRAMINE HCl
PHENYLEPHRINE HCl

Pain reliever, Antihistamine
Nasal decongestant

For Allergy Plus Sinus Pain
& Pressure Relief of:
Sneezing, Runny nose, Sinus headache,
Sinus congestion, Sinus pain & pressure,
Itchy, watery eyes

20 CAPLETS
Capsule-Shaped Tablets

Actual Size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-18615

CVS®Quality
Money Back Guarantee

50844 REV0918C54309

CVS Health 44-543

SEVERE ALLERGY AND SINUS HEADACHE MAXIMUM STRENGTH
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-543
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN
CROSPOVIDONE, UNSPECIFIED
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN

Product Characteristics
Color	BLUE	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	44;543
Contains

Packaging
#	Item Code	Package Description
1	NDC:59779-543-09	2 BLISTER PACK in 1 CARTON
1		10 TABLET, FILM COATED in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/27/2007