NDC | 44224-0001-2, 52124-0001-1, 52124-0003-1, 52124-0014-1, 52124-0015-1, 52124-0016-1, 52124-0017-1, 69842-404-00 |
Set ID | 4664c90e-276e-0f6e-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | CVS |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333A |
- Active Ingredients - Genuine Triple Antibiotic
- Purpose - Genuine Triple Antibiotic
- Uses - Genuine Triple Antibiotic
- Warnings - Genuine Triple Antibiotic
- DO NOT USE - Genuine Triple Antibiotic
- Stop Use - Genuine Triple Antibiotic
- Keep Out of Reach of Children - Genuine Triple Antibiotic
- Directions - Genuine Triple Antibiotic
- Storage and Handling - Genuine Triple Antibiotic
- Inactive Ingredients - Genuine Triple Antibiotic
- Active Ingredients - Antiseptic
- Purpose - Antiseptic
- Use - Antiseptic
- Warnings - Antiseptic
- Keep out of reach of children - Antiseptic
- Stop Use - Antiseptic
- Do Not Use - Antiseptic
- Directions - Antiseptic
- Inactive Ingredients - Antiseptic
- Active Ingredients - Non-Aspirin
- Purpose - Non Aspirin
- Uses - Non Aspirin
-
Warnings - Non Aspirin
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product
- Do Not Use - Non Aspirin
- Ask a Doctor - Non Aspirin
- Stop Use - Non Aspirin
- Pregnancy - Non Aspirin
- Keep Out of Reach of Children - Non Aspirin
- Inactive Ingredients - Non Aspirin
-
Directions - Non Aspirin
Directions
Adults and Children Take 2 tablets every 4 to 6 hours as
12 years of age needed. Do not take more than 12 tablets
or older in 24 hours.
Children 6-11 years Take 1 tablet every 4 to 6 hours as
of age needed. Do not take more than 5
tablets in 24 hours.
Children under 6 Do not use this regular strength product.
years of age This will provide more than the
recommended dose (overdose) and could
cause serious health problems.
- Storage and Handling - Non Aspirin
- Active Ingredients - After Bite
- Purpose - After Bite
- Uses - After Bite
- Warnings - After Bite
- Keep Out of Reach of Children - After Bite
- Stop Use - After Bite
- When Using - After Bite
- DIrections - After Bite
- Active Ingredient - Aspirin
- Purpose
- Uses - Aspirin
-
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of 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.
Allergy Alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock. If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The change is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks everyday while using this product, take more for a longer time than directed
-
Do Not Use - Aspirin
Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis.
Ask a doctor before use if: 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 or kidney disease; you are taking a diuretic.
Ask a doctor or pharmacist before use if you are: under a doctor's care for any serious condition; taking any other drug.
When using this product: Take with food or milk if stomach upset occurs.
-
Stop Use and ask a Doctor - Aspirin
Stop Use and ask a Doctor if:
You experience any of the following signs of stomach bleeding, you feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, you have difficulty swallowing, if ringing in the ears or loss of hearing occurs, redness or swelling is present in painful areas, or any new symptoms appear.
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of Children. In case of overdose, get medical help or contact a poison control center right away.
-
Directions - Aspirin
Do not use more than directed - the smallest effective dose should be used.
Drink a full glass of water with each dose.
Do not take longer than 10 days, unless directed by a doctor.
Adults and Children (12 years and older): take 1 or 2 tablets with water every 4 hours as needed. Do not take more then 12 tablets in 24 hours, or as directed by a doctor.
Children under 12 years: Do not give to children under 12 years of age.
Avoid excessive heat and humidity, do not use any open or torn packets.
- Inactive Ingredients - Aspirin
- Active Ingredient - Diphenhydramine
- Purpose - Diphenhydramine
- Use - Diphenhydramine
-
Warnings
Ask a doctor before use if you have: a breathing problem such as emphyseme or chronic bronchitis, glaucoma, difficulty in urination due to enlargement of the prostate gland; or if you are: taking any drugs for asthma, sedatives or tranquilizers.
When using this product: Drowziness may occur, avoid alcoholic beverages.
Alcohol, sedatives and tranquilizers may increase the drowziness effect. Use caution when driving a motor vehicle or operating machinery. Excitality may occur, especially in children.
Keep out of Reach of Children
Do not exceed recommended dosage. Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using the product.
- Dosage - Diphenhydramine
- Inactive Ingredients
- Active Ingredient - Alcohol Pad
- Uses - Alcohol Prep Pad
-
Warnings - Alcohol Prep Pad
For External Use Only
Flammable - Keep away from fire or flame
Do Not Use - with electrocautery, in eyes
Stop Use and Ask a Doctor if - Irritation or redness develop and persists for more than 72 hours
Keep out of Reach of Children
If Swallowed, get medical help or contact a poison control center right away
- Directions - Alcohol Prep Pad
- Inactive Ingredients - Alcohol Pad
- Packaging
-
INGREDIENTS AND APPEARANCE
CVS HEALTH MEDICATION AND TOPICAL REFILL POUCH
aspirin, diphenhydramine hydrochloride, aspirin, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, acetaminophen kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-404 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-404-00 1 in 1 BAG; Type 0: Not a Combination Product 12/28/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKET 2 Part 2 4 PACKAGE 3 mL in .7 Part 3 4 PACKAGE 3 mL in .7 Part 4 1 PACKAGE 2 Part 5 15 PACKAGE 12 mL in .8 Part 6 6 TUBE 3 g in .5 Part 7 2 PACKET 4 Part 1 of 7 DIPHENHYDRAMINE
diphenhydramine hydrochloride capsuleProduct Information Item Code (Source) NDC:52124-0016 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) STARCH, CORN (UNII: O8232NY3SJ) D&C RED NO. 28 (UNII: 767IP0Y5NH) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color pink Score no score Shape CAPSULE Size 14mm Flavor Imprint Code CPC;835 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0016-1 2 in 1 PACKET; 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 12/01/2016 Part 2 of 7 ALCOHOL PREP PAD
isopropyl alcohol swabProduct Information Item Code (Source) NDC:52124-0017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 700 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0017-1 0.7 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/01/2017 Part 3 of 7 AFTER BITE WIPE
ammonia swabProduct Information Item Code (Source) NDC:44224-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE 1000 (UNII: MCU2324216) LIGHT MINERAL OIL (UNII: N6K5787QVP) C12-13 ALCOHOLS (UNII: T7ZJT3I9X2) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44224-0001-2 0.7 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/28/2016 Part 4 of 7 NON-ASPIRIN
acetaminophen tabletProduct Information Item Code (Source) NDC:52124-0014 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code AZ;234 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0014-1 2 in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/28/2016 Part 5 of 7 ANTISEPTIC
benzalkonium chloride swabProduct Information Item Code (Source) NDC:52124-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0001-1 0.8 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/28/2016 Part 6 of 7 GENUINE TRIPLE ANTIBIOTIC
bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointmentProduct Information Item Code (Source) NDC:52124-0003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0003-1 0.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 12/28/2016 Part 7 of 7 ASPIRIN
aspirin tabletProduct Information Item Code (Source) NDC:52124-0015 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code 44;157;ASPIRIN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52124-0015-1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 12/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/28/2016 Labeler - CVS (062312574) Establishment Name Address ID/FEI Business Operations Tender Corporation 064437304 manufacture(69842-404)