| NDC | 0067-2000-91, 0067-2056-24, 0067-8148-01 |
| Set ID | 444fa225-c204-45d1-b3b3-aa5650ee5d07 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- Excedrin PM Headache
- Active ingredients (in each caplet)
- Purposes
- Uses
-
Warnings
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.
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.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- •
- hives
- •
- facial swelling
- •
- asthma (wheezing)
- •
- shock
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 2 caplets 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
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
Do not use
- •
- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
- •
- 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
- •
- in children under 12 years of age
Ask a doctor before use if
- •
- you have liver disease
- •
- 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
- •
- you have asthma
- •
- you have glaucoma
- •
- you have a breathing problem such as emphysema or chronic bronchitis
- •
- you have trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking
- •
- a prescription drug for:
- •
- diabetes
- •
- gout
- •
- arthritis
- •
- any other drug, or are under a doctor’s care for any serious condition
- •
- any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
- •
- sedatives or tranquilizers
When using this product
- •
- drowsiness will occur
- •
- avoid alcoholic drinks
- •
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- •
- an allergic reaction occurs. Seek medical help right away.
- •
- you experience any of the following signs of stomach bleeding:
- •
- feel faint
- •
- vomit blood
- •
- have bloody or black stools
- •
- have stomach pain that does not get better
- •
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- •
- pain gets worse or last for more than 10 days
- •
- painful area is red or swollen
- •
- ringing in the ears or a loss of hearing occurs
- •
- any new symptoms occur
These could be signs of a serious condition
- Directions
- Other information
-
Inactive ingredients
benzoic acid, calcium carbonate, FD&C blue#1 aluminum lake, hydroxypropyl cellulose low substituted, hypromellose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate
- Questions or comments?
- Excedrin Extra Strength
- Active ingredients (in each caplet)
- Purposes
- Uses
-
Warnings
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.
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.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- •
- hives
- •
- facial swelling
- •
- asthma (wheezing)
- •
- shock
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 8 caplets 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
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
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat.
Do not use
- •
- if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
- •
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
- •
- you have liver disease
- •
- 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
- •
- you have asthma
Ask a doctor or pharmacist before use if you are taking
- •
- a prescription drug for diabetes, gout, or arthritis
- •
- any other drug, or are under a doctor’s care for any serious condition
Stop use and ask a doctor if
- •
- an allergic reaction occurs. Seek medical help right away.
- •
- you experience any of the following signs of stomach bleeding:
- •
- feel faint
- •
- vomit blood
- •
- have bloody or black stools
- •
- have stomach pain that does not get better
- •
- ringing in the ears or a loss of hearing occurs
- •
- painful area is red or swollen
- •
- pain gets worse or last for more than 10 days
- •
- fever gets worse or lasts for more than 3 days
- •
- any new symptoms occur
These could be signs of a serious condition
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel (Excedrin PM Headache)
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. USE PRODUCTS AS DIRECTED.
NDC 0067-2056-24
EXCEDRIN®
PM HEADACHE
Acetaminophen, Aspirin (NSAID) and Diphenhydramine Citrate
Pain Reliever/Nighttime Sleep-Aid
Triple Action Formula
Caffeine-Free
Non-Habit Forming
24 CAPLETS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
©2015 GSK or its licensor.
Visit us at www.excedrin.com
46172695
-
Principal Display Panel (Excedrin Extra Strength)
NDC 0067-2000-91
EXCEDRIN®
EXTRA STRENGTH
Acetaminophen, Aspirin (NSAID) and Caffeine
Pain Reliever / Pain Reliever Aid
100 CAPLETS
TAMPER-EVIDENT BOTTLE
DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
©2015 GSK group of companies or its licensor. All rights reserved.
Visit us at www.excedrin.com
DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME. USE PRODUCTS AS DIRECTED.
46172044
-
INGREDIENTS AND APPEARANCE
EXCEDRIN PM TRIPLE ACTION CAPLETS AND EXCEDRIN EXTRA STRENGTH PAIN RELIEVER
acetaminophen, aspirin (nsaid), caffeine, and diphenhydramine citrate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-8148 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-8148-01 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 05/01/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 24 Part 2 1 BOTTLE 100 Part 1 of 2 EXCEDRIN PM TRIPLE ACTION CAPLETS
acetaminophen, aspirin (nsaid) and diphenhydramine citrate tablet, coatedProduct Information Item Code (Source) NDC:0067-2056 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg DIPHENHYDRAMINE CITRATE (UNII: 4OD433S209) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE CITRATE 38 mg Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) CALCIUM CARBONATE (UNII: H0G9379FGK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYDEXTROSE (UNII: VH2XOU12IE) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ZINC STEARATE (UNII: H92E6QA4FV) Product Characteristics Color BLUE (light blue) Score no score Shape RECTANGLE Size 17mm Flavor Imprint Code EXPM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-2056-24 1 in 1 CARTON 1 24 in 1 BOTTLE; 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 09/24/2014 Part 2 of 2 EXCEDRIN EXTRA STRENGTH PAIN RELIEVER
acetaminophen, aspirin (nsaid), and caffeine tablet, film coatedProduct Information Item Code (Source) NDC:0067-2000 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) CARNAUBA WAX (UNII: R12CBM0EIZ) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LIGHT MINERAL OIL (UNII: N6K5787QVP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 20 (UNII: 7T1F30V5YH) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White) Score no score Shape CAPSULE (Capsule-Shaped Tablet) Size 18mm Flavor Imprint Code E Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-2000-91 1 in 1 CARTON 1 100 in 1 BOTTLE; 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 09/27/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/01/2018 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
