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- NDC Code(s): 0363-0715-01
- Packager: WALGREENS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 15, 2022
If you are a consumer or patient please visit this version.
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- DRUG FACTS
- ACTIVE INGREDIENT
Active ingredients
(in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg - PURPOSE
-
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
- WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- if you have ever had an allergic reaction to this product or any of its ingredients
- ASK DOCTOR
Ask a doctor before use if you have
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
- ASK DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- WHEN USING
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
- STOP USE
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. -
Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over:
- take 2 caplets at bedtime
- do not take more than 2 caplets of this product in 24 hours.
children under 12 years:
- do not use
- OTHER INFORMATION
Other information
- store between 20-25°C (68-77°F)
- INACTIVE INGREDIENT
Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium starch glycolate**, stearic acid, talc, titanium dioxide
**may contain this ingredient - QUESTIONS
Questions or comments? call 1-877-290-4008
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
EXTRA STRENGTH NITE-TIME PAIN RELIEF
430r walgreens acetaminophen 500 mg,diphenhydramine hcl 25 mg tablet tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0715 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) CARNAUBA WAX (UNII: R12CBM0EIZ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape CAPSULE Size 20mm Flavor Imprint Code TCL430 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0715-01 1 in 1 CARTON 10/12/2021 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 10/12/2021 Labeler -WALGREENS(008965063)
Registrant -TIME CAP LABORATORIES, INC. (037052099)
Establishment Name Address ID/FEI Business Operations TIME CAP LABORATORIES, INC. 037052099 manufacture(0363-0715)
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More Info on this Drug
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View Labeling Archives for this drug
EXTRA STRENGTH NITE-TIME PAIN RELIEF- 430r walgreens acetaminophen 500 mg,diphenhydramine hcl 25 mg tablet tablet
Number of versions: 2
Published Date (What is this?) | Version | Files |
---|---|---|
Jul 18, 2022 | 3 (current) | download |
Oct 12, 2021 | 2 | download |
RxNorm
EXTRA STRENGTH NITE-TIME PAIN RELIEF- 430r walgreens acetaminophen 500 mg,diphenhydramine hcl 25 mg tablet tablet
RxCUI | RxNorm NAME | RxTTY | |
---|---|---|---|
1 | 1092189 | acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet | PSN |
2 | 1092189 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SCD |
3 | 1092189 | APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SY |
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NDC Codes
EXTRA STRENGTH NITE-TIME PAIN RELIEF- 430r walgreens acetaminophen 500 mg,diphenhydramine hcl 25 mg tablet tablet
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
NDC | |
---|---|
1 | 0363-0715-01 |