Diphen

Diphen
SPL v1
SPL
SPL Set ID 5d185f23-8af6-4e36-b514-5662986520a5
Routes
TOPICAL ORAL
Published
Effective Date 2022-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg) Benzalkonium (1.3 mg) Hydrocortisone (5 mg) Bacitracin (10 mg) Neomycin (400 [USP'U]) Polymyxin B (3.5 mg) Carbonate Ion (5000 [USP'U]) Ibuprofen (420 mg) Loratadine (325 mg) Acetaminophen (15 mg) Dextromethorphan (25 mg) Guaifenesin (27 mg) Phenylephrine (80 mg) Diphenhydramine (20 mg) Chloride Ion (500 mg) Magnesium Cation (262 mg) Meclizine Bismuth Cation
Inactive Ingredients
Polyethylene Glycol 400 Polyethylene Glycol 3350 Peppermint Oil Saccharin Sodium Sorbic Acid Alcohol Methylparaben Mineral Oil Paraffin Propylparaben Water White Petrolatum White Wax Petrolatum Fd&c Blue No. 1 Fd&c Green No. 3 D&c Green No. 5 Fd&c Red No. 3 D&c Red No. 28 Fd&c Red No. 40 Fd&c Yellow No. 5 Fd&c Yellow No. 6 Aspartame Croscarmellose Sodium Acacia Magnesium Stearate Maltodextrin Sorbitol Sucrose Carnauba Wax Starch, Corn Hypromellose, Unspecified Ferric Oxide Red Lactose, Unspecified Form Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone K30 Silicon Dioxide Sodium Starch Glycolate Type A Stearic Acid Talc Titanium Dioxide Lactose Monohydrate Povidone, Unspecified D&c Red No. 27 Anhydrous Dibasic Calcium Phosphate Anhydrous Lactose D&c Yellow No. 10 Calcium Carbonate Dextrates

Identifiers & Packaging

Pill Appearance
Imprint: RH;046 Shape: round Shape: capsule Color: white Color: brown Color: pink Color: yellow Size: 11 mm Size: 10 mm Size: 6 mm Size: 12 mm Size: 9 mm Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2022-05-10

Description

REMEDY PACK

Purpose

First aid antibiotics


Medication Information

Purpose

Topical antiseptic, Topicall analgesic

Description

REMEDY PACK

Uses

First aid to help prevent infection in minor cuts, scrapes and burns.

For the temporary relief of pain and itching associated with:

  • sunburn
  • insect bites
  • cuts
  • minor skin irritations
  • scrapes
  • minor burns
Section 42229-5

REMEDY PACK

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1
  • do not use for the treatment of diaper rash.
Section 53414-9

If pregnant or breast feeding, ask a health care professional before use.

Section 55105-1
Active ingredient (in each tablet): Acetaminophen 325mg Purpose: Pain reliever/ fever reducer
Active ingredient (in each tablet): Dextromethorphan Hydrobromide 15mg Purpose: Cough suppressant
Active ingredient (in each tablet): Guaifenesin 200mg Purpose: Expectorant
Active ingredient (in each tablet): Phenylephrine HCl 5mg Purpose: Nasal decongestant
Section 55106-9
Amount Per Serving % Daily Value
Calcium (from 27.0 mg calcium carbonate) 10.8 mg 1.06%
Potassium (from 80 mg potassium chloride) 40mg 1.15%
Magnesium (from 20 mg magnesium oxide) 12 mg 3.0%
Carbohydrates 6 mg >1%
Calories 1.5 >1%
Protein 0%
Fat 0%
Warning

For external use only.

Purposes

First aid antibiotics

Directions

Adults and children 2 years and over:

  • clean the affected area
  • apply a small amount of this product on the area 3 to 4 times daily
  • may be covered with a sterile bandage
  • Children under 12 years: consult a doctor
  • Children under 2 years: consult a doctor
Do Not Use
  • in the eyes
  • over large areas of the body or on deep puncture wounds, animal bites, or serious burns
  • in large quantities, particularly over raw surfaces or blistered areas
Information

Serving Size: 2 tablets

Servings Per Packet: 1

Allergy Alert

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other " caine" anesthetics.

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.

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Reye's Syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome a rare but serious illness.

Other Information
  • store in a cool, dry area 59° to 79°F (15° to 25°C)
  • tamper evident sealed packets
  • do not use any opened or torn packets
Other Ingredients

microcrystalline cellulose, silicon dioxide, stearic acid, magnesium stearate

Active Ingredients

Benzalkonium Chloride 0.13%, Lidocaine HCl 0.5%

Inactive Ingredients

decolorized aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Inactive Ingredients*

maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Do Not Use If You Have
  • bloody or black stool
  • an ulcer
  • a bleeding problem
Ask A Doctor Before Use

in case of deep or puncture wounds, animal bites, or serious burns

When Using This Product

avoid contact with eyes. If it occurs, flush with water.

Stomach Bleeding Warning

This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack or stroke warning: NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke.

These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Methemoglobinemia Warning

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood.

This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy
Ask A Doctor Before Use If
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • stomach bleeding warning applies to you
  • you have a history of stomach problems such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
  • you are taking a diuretic
Stop Use and Ask Doctor If
  • the condition gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 days
Stop Use and Ask A Doctor If

the condition persists or gets worse a rash or other allergic reaction develops

Stop Using and Ask A Doctor If
  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present
Inactive Ingredientsmay Contain

aspartame

, croscarmellose sodium
, gum acacia
, magnesium stearate, maltodextrin, mineral oil
, mint flavor, sorbitol
, sucrose

Inactive Ingredientsmay Contain

carnauba wax

, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate
, hypromellose, lactose
, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate
, titanium dioxide

Active Ingredient (in Each Gram)

Bacitracin zinc (400 units), Neomycin sulfate 5 mg (equivalent to 3.5 mg of Neomycin), Polymyxin-B sulfate 5000 units

Active Ingredient (in Each Tablet)

Calcium Carbonate 420mg

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema
Principal Display Panel Kit Carton

REMEDY PACK

DRUG FACTS

www.theremedypack.com

Ask A Doctor Or Pharmacist Before Use If
  • you are taking the blood thinning drug warfarin
Ask A Doctor Or Pharmacist Before Use If You Are
  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Ask A Doctor Or Pharmacist If You Are Taking Any Drug For
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Structured Label Content

Uses (USES)

First aid to help prevent infection in minor cuts, scrapes and burns.

For the temporary relief of pain and itching associated with:

  • sunburn
  • insect bites
  • cuts
  • minor skin irritations
  • scrapes
  • minor burns
Section 42229-5 (42229-5)

REMEDY PACK

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)
  • do not use for the treatment of diaper rash.
Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health care professional before use.

Section 55105-1 (55105-1)
Active ingredient (in each tablet): Acetaminophen 325mg Purpose: Pain reliever/ fever reducer
Active ingredient (in each tablet): Dextromethorphan Hydrobromide 15mg Purpose: Cough suppressant
Active ingredient (in each tablet): Guaifenesin 200mg Purpose: Expectorant
Active ingredient (in each tablet): Phenylephrine HCl 5mg Purpose: Nasal decongestant
Section 55106-9 (55106-9)
Amount Per Serving % Daily Value
Calcium (from 27.0 mg calcium carbonate) 10.8 mg 1.06%
Potassium (from 80 mg potassium chloride) 40mg 1.15%
Magnesium (from 20 mg magnesium oxide) 12 mg 3.0%
Carbohydrates 6 mg >1%
Calories 1.5 >1%
Protein 0%
Fat 0%
Purpose

Topical antiseptic, Topicall analgesic

Warning (WARNING)

For external use only.

Purposes

First aid antibiotics

Directions (DIRECTIONS)

Adults and children 2 years and over:

  • clean the affected area
  • apply a small amount of this product on the area 3 to 4 times daily
  • may be covered with a sterile bandage
  • Children under 12 years: consult a doctor
  • Children under 2 years: consult a doctor
Do Not Use (Do not use)
  • in the eyes
  • over large areas of the body or on deep puncture wounds, animal bites, or serious burns
  • in large quantities, particularly over raw surfaces or blistered areas
Information (INFORMATION)

Serving Size: 2 tablets

Servings Per Packet: 1

Allergy Alert (ALLERGY ALERT)

do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other " caine" anesthetics.

Allergy Alert (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.

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Reye's Syndrome (Reye's syndrome)

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome a rare but serious illness.

Other Information (OTHER INFORMATION)
  • store in a cool, dry area 59° to 79°F (15° to 25°C)
  • tamper evident sealed packets
  • do not use any opened or torn packets
Other Ingredients (OTHER INGREDIENTS)

microcrystalline cellulose, silicon dioxide, stearic acid, magnesium stearate

Active Ingredients (Active ingredients)

Benzalkonium Chloride 0.13%, Lidocaine HCl 0.5%

Inactive Ingredients (INACTIVE INGREDIENTS)

decolorized aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Inactive Ingredients* (INACTIVE INGREDIENTS*)

maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Do Not Use If You Have (Do not use if you have)
  • bloody or black stool
  • an ulcer
  • a bleeding problem
Ask A Doctor Before Use (Ask a doctor before use)

in case of deep or puncture wounds, animal bites, or serious burns

When Using This Product (When using this product)

avoid contact with eyes. If it occurs, flush with water.

Stomach Bleeding Warning (Stomach bleeding warning)

This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Heart attack or stroke warning: NSAIDS, except aspirin, increase the risk of heart attack, heart failure, and stroke.

These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Methemoglobinemia Warning (METHEMOGLOBINEMIA WARNING)

Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood.

This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:

  • pale, gray, or blue colored skin (cyanosis)
  • headache
  • rapid heart rate
  • shortness of breath
  • dizziness or lightheadedness
  • fatigue or lack of energy
Ask A Doctor Before Use If (Ask a doctor before use if)
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • stomach bleeding warning applies to you
  • you have a history of stomach problems such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
  • you are taking a diuretic
Stop Use and Ask Doctor If (Stop use and ask doctor if)
  • the condition gets worse
  • condition clears up and recurs within a few days
  • condition persists for more than 7 days
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

the condition persists or gets worse a rash or other allergic reaction develops

Stop Using and Ask A Doctor If (Stop using and ask a doctor if)
  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present
Inactive Ingredientsmay Contain (INACTIVE INGREDIENTSmay contain)

aspartame

, croscarmellose sodium
, gum acacia
, magnesium stearate, maltodextrin, mineral oil
, mint flavor, sorbitol
, sucrose

Inactive Ingredientsmay Contain (Inactive Ingredientsmay contain)

carnauba wax

, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate
, hypromellose, lactose
, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate
, titanium dioxide

Active Ingredient (in Each Gram) (Active Ingredient (in each gram))

Bacitracin zinc (400 units), Neomycin sulfate 5 mg (equivalent to 3.5 mg of Neomycin), Polymyxin-B sulfate 5000 units

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Calcium Carbonate 420mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema
Principal Display Panel Kit Carton (PRINCIPAL DISPLAY PANEL - Kit Carton)

REMEDY PACK

DRUG FACTS

www.theremedypack.com

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)
  • you are taking the blood thinning drug warfarin
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Ask A Doctor Or Pharmacist If You Are Taking Any Drug For (Ask a doctor or pharmacist if you are taking any drug for)
  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)