![WAL-PHED PE, MULTI-SYMPTOM (ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]](https://medic.hrt.org//dailymed/images/687038fc-1a1b-4cee-bdd8-3c4161d5f58c/walgreens-44-526-1.jpg)
| NDC | 0363-0526-07, 0363-0526-08 |
| Set ID | 687038fc-1a1b-4cee-bdd8-3c4161d5f58c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Walgreen Company |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each caplet)
- Purpose
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg in 24 hours, which is the maximum daily amount
- 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:
- blisters
- rash
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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
- liver disease
- thyroid disease
- heart disease
- diabetes
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- cough accompanied by too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- high blood pressure
- a breathing problem such as emphysema or chronic bronchitis
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
- avoid alcoholic beverages
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough 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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
BONUS SIZE BUY 24 & GET 12 FREE NDC 0363-0526-07
Walgreens
Compare to Sudafed PE® Severe Cold active ingredients††
Wal-Phed® PESEVERE COLD
ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER / DIPHENHYDRAMINE HCl 12.5 mg /
ANTIHISTAMINE / COUGH SUPPRESSANT / PHENYLEPHRINE HCl 5 mg / NASAL DECONGESTANT
MULTI-SYMPTOM
• Relieves sore throat, head & body aches, cough,
runny nose, sneezing, sinus pressure & congestion• Pseudoephedrine free
36 CAPLETS (24 + 12 FREE)
Actual Size
DOES NOT CONTAIN GLUTEN
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††This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Severe Cold.
50844 ORG061652607
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2017 Walgreen Co.
44-526
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INGREDIENTS AND APPEARANCE
WAL-PHED PE, MULTI-SYMPTOM
acetaminophen, diphenhydramine hcl and phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0526 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color WHITE Score no score Shape OVAL Size 18mm Flavor Imprint Code 44;526 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0526-08 2 in 1 CARTON 06/21/2005 05/15/2021 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0363-0526-07 3 in 1 CARTON 06/21/2005 2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/21/2005 Labeler - Walgreen Company (008965063) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(0363-0526) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(0363-0526)