Label: DEFENSOL D BLISTER PACK- acetaminophen, diphenhydramine hcl, phenylephrine hci tablet
- NDC Code(s): 53145-009-30
- Packager: Menper Distributors, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 22, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
Temporarily relieves these symptoms associated with cold or flu:
- headache
- nasal congestion
- sore throat
- fever
- minor aches and pains
- Temporarily relieves minor aches, pains, and headache as well as those symptoms of hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- nasal congestion
- itching of the nose or throat
- itchy, watery eyes
Temporarily relieves minor aches, pains, headache, and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages
-
WARNINGS
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tablets in any 24-hour period, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Severe throat warning:if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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
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 MADI drug. If you do not know if your prescription drug contains MADI, ask a doctor or
pharmacist befaretakingthisprocluct.
■ if you have ever had an allergic reaction to this product or any of its ingredients
■ to sedate a child or to make a child sleepy
■ with any other product containing diphenhydramine, even one used on skin. -
ASK DOCTOR
Ask doctor before use if you have
- liver desease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem such as emphysema, asthma, or chronic bronchitis
- taking the blood thinning drug warfarin
- taking any other oral nasal decongestant or stimulant
- taking any other pain relieve/fever reducer
- taking sedatives or tranquilizers
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
-
DOSAGE & ADMINISTRATION
Directions: do not take more than 12 tablets in a 24 hour period.
- do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. This adult product is not intended for use in children under 12 years of age
age dose adults and children 12 years and over 2 tablets every 4 hours children under 12 years do not use -
INACTIVE INGREDIENT
Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, FD&C blue#1 aluminum lake, FO&C blue#2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid, and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, s I con dioxide, sodium bicarbonate, stearic acid, talc, titanium oxide. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DEFENSOL D BLISTER PACK
acetaminophen, diphenhydramine hcl, phenylephrine hci tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53145-009 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM BICARBONATE (UNII: 8MDF5V39QO) TALC (UNII: 7SEV7J4R1U) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) (UNII: XRK36F13ZZ) CROSPOVIDONE (UNII: 2S7830E561) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) Product Characteristics Color blue Score 2 pieces Shape RECTANGLE Size 10mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53145-009-30 1 in 1 BOX 01/01/2024 1 30 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 01/01/2024 Labeler - Menper Distributors, Inc. (101947166) Establishment Name Address ID/FEI Business Operations LNK International, Inc 868734088 manufacture(53145-009)

