NDC | 0135-0608-01, 0135-0608-02, 0135-0608-03, 0135-0608-04 |
Set ID | 01e7dddb-755c-4745-b701-edcdb6209064 |
Category | HUMAN OTC DRUG LABEL |
Packager | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART343 |
- Active ingredients (in each caplet)
- Purposes
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert:
acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- with any other product containing diphenhydramine, even one used on skin
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- in children under 12 years of age
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- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
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- liver disease
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- glaucoma
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- a breathing problem such as emphysema or chronic bronchitis
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- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking
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- the blood thinning drug warfarin
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- sedatives or tranquilizers
When using this product
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- drowsiness will occur
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- avoid alcoholic drinks
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- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
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- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
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- pain gets worse or lasts more than 10 days
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- redness or swelling is present
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- any new symptoms appear
These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
NDC 0135-0608-01
PANADOL
EXTRA STRENGTH
PM
ACETAMNOPHEN
Pain Reliever
DIPHENHYDRAMINE HCl
Nighttime Sleep-Aid
24 CAPLETS
Tamper-Evident Feature: Do not use if printed bottle seal (under cap) is missing or broken.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
Trademarks are owned by or licensed to the GSK group of companies.
Distributed by:
GSK Consumer Healthcare, Warren, NJ 07059
©2016 GSK group of companies or its licensor.
101639XE
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INGREDIENTS AND APPEARANCE
PANADOL PM
acetaminophen and diphenhydramine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0608 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape OVAL (Caplet) Size 17mm Flavor Imprint Code PM Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0608-01 1 in 1 CARTON 12/01/2016 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0135-0608-02 1 in 1 CARTON 12/01/2016 2 50 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0135-0608-03 50 in 1 CARTON 12/01/2016 3 NDC:0135-0608-04 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 not final part343 12/01/2016 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)