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NDC 00363-0543-09 Wal-Dryl 325; 25; 5 mg/1; mg/1; mg/1 Details

Wal-Dryl 325; 25; 5 mg/1; mg/1; mg/1

Wal-Dryl is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 00363-0543-09
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Related Packages: 00363-0543-09
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diphenhydramine

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 00363-0543-09
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	00363-0543
Product ID	0363-0543_163abe1a-9d4c-40d0-8f49-38f789688a82
Associated GPIs	43994003900340
GCN Sequence Number	061336
GCN Sequence Number Description	diphenhyd/phenyleph/acetaminop TABLET 25-5-325MG ORAL
HIC3	B3O
HIC3 Description	1ST GEN ANTIHISTAMINE-DECONGESTANT-ANALGESIC COMB
GCN	97128
HICL Sequence Number	035433
HICL Sequence Number Description	DIPHENHYDRAMINE HCL/PHENYLEPHRINE HCL/ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	Wal-Dryl
Proprietary Name Suffix	Maximum Strength
Non-Proprietary Name	Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	325; 25; 5
Active Ingredient Units	mg/1; mg/1; mg/1
Substance Name	ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Walgreen Company
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	n/a

Package

Package Images

NDC 00363-0543-09 (00363054309)

Pricing Information	N/A
NDC Package Code	0363-0543-09
Billing NDC	00363054309
Package	2 BLISTER PACK in 1 CARTON (0363-0543-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2007-06-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 09bb548f-f833-4eec-bacc-e4f1e71f5cf2 Details

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

Walgreens

NDC 0363-0543-09

Wal-Dryl®

SEVERE ALLERGY & SINUS HEADACHE

ACETAMINOPHEN / PAIN RELIEVER

DIPHENHYDRAMINE HCl / ANTIHISTAMINE

PHENYLEPHRINE HCl / NASAL DECONGESTANT

MAXIMUM STRENGTH CAPLETS

• Relief of headache, sinus congestion, sinus pain & pressure,

runny nose, sneezing, itchy throat & itchy, watery eyes

• Upper respiratory allergies only

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

Walgreens Pharmacist Recommended

Walgreens Pharmacist Survey

50844 ORG091854309

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD, DEERFIELD IL 60015

100% SATISFACTION GUARANTEED

walgreens.com

©2018 Walgreen Co.

44-543

INGREDIENTS AND APPEARANCE

WAL-DRYL MAXIMUM STRENGTH

acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0543
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 2S7830E561)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0543-09	2 in 1 CARTON	06/27/2007	12/14/2023
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/27/2007	12/14/2023

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(0363-0543)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-0543)

Revised: 11/2022

Document Id: 163abe1a-9d4c-40d0-8f49-38f789688a82

Set id: 09bb548f-f833-4eec-bacc-e4f1e71f5cf2

Version: 12

Effective Time: 20221119