Label: SEVERE ALLERGY PLUS SINUS HEADACHE- acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
- NDC Code(s): 49035-543-09, 49035-543-41
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 25, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
equate™
NDC 49035-543-09
Quality
GuaranteedMaximum Strength
Severe Allergy
Plus Sinus Headache
Acetaminophen, Diphenhydramine HCl,
Phenylephrine HCl
Pain Reliever/Antihistamine/Nasal Decongestant
Relieves:
• Sinus headache
• Sinus congestion
• Sinus pressure
• Sneezing
• Runny nose
• Itchy throat
• Itchy, watery eyes20
CAPLETSActual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERINGDISTRIBUTED BY:
Walmart Inc.,
Bentonville, AR 7271650844 REV0918G54309
Satisfaction guaranteed –
Or we’ll replace it or give
you your money back.
For questions or
comments please call
1-888-287-1915.Equate 44-543
-
INGREDIENTS AND APPEARANCE
SEVERE ALLERGY PLUS SINUS HEADACHE
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-543 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 25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE, UNSPECIFIED (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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-543-41 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 06/27/2007 2 NDC:49035-543-09 2 in 1 CARTON 06/27/2007 2 10 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 Drug M012 06/27/2007 Labeler - Wal-Mart Stores Inc (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(49035-543) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(49035-543)