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NDC 81533-0500-30 NobleAid 500 mg/1 Details

NobleAid 500 mg/1

NobleAid is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Noble Otc LLC. The primary component is ACETAMINOPHEN.

MedlinePlus Drug Summary

Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Related Packages: 81533-0500-30
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen

Product Information

NDC	81533-0500
Product ID	81533-500_6983b2fd-9ea0-4bca-9f47-14eadddc94cd
Associated GPIs	64200010000315
GCN Sequence Number	004490
GCN Sequence Number Description	acetaminophen TABLET 500 MG ORAL
HIC3	H3E
HIC3 Description	ANALGESIC/ANTIPYRETICS,NON-SALICYLATE
GCN	16965
HICL Sequence Number	001866
HICL Sequence Number Description	ACETAMINOPHEN
Brand/Generic	Generic
Proprietary Name	NobleAid
Proprietary Name Suffix	n/a
Non-Proprietary Name	Acetaminophen
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	ACETAMINOPHEN
Labeler Name	Noble Otc LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part343
Listing Certified Through	n/a

Package

Package Images

NDC 81533-0500-30 (81533050030)

Pricing Information	N/A
NDC Package Code	81533-500-30
Billing NDC	81533050030
Package	300 TABLET, FILM COATED in 1 BOTTLE (81533-500-30)
Marketing Start Date	2021-05-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL df5c0266-036c-435a-95f0-42d57c7fb8e3 Details

DRUG FACTS

ACTIVE INGREDIENT (in each caplet)

Acetaminophen 500mg

PURPOSE

Pain reliever/fever reducer

Uses

• Temporarily relieves minor aches and pains due to:

• Headache • Muscular aches

• Backache • Minor pain of Arthritis

• Common cold • Toothache

• Premenstrual and menstrual cramps

• temporarily reduces fever.

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

with any other drug containing acetaminophen (prescription or nonprescription).

If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a Doctor before use if you have liver disease

Ask a Doctor before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain gets worse or last more than 10 days

• fever gets worse or last more than 3 days

• new symptoms occur redness or swelling is present.

This could be signs of serious condition.

If pregnant or breastfeeding, ask a health professional before use

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 & Children 12 years and over	Take 2 caplets every 6 hours while symptoms last. Do not take more than 6 caplets in 24 hours, unless directed by a doctor. Do not use more than 10 days unless directed by a doctor.
Children under 12 years	Ask a doctor

Inactive Ingredients

FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, mica-based pearlescent pigment, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Other Information

Store at 20-25 C (68-77 F)

SPL UNCLASSIFIED SECTION

ACETAMINOPHEN CAPLETS

EXTRA STRENGTH

RAPID RELEASE PAIN RELIEF

Compare to the Active Ingredient in Tylenol©

Extra Strength Rapid Release Gels

√ Pain Reliever

√ Fever Reducer

√ Aspirin Free

For Adults

DO NOT USE IF THE PRINTED SEAL UNDER CAP IS BROKEN OR MISSING

Manufactured for

Noble OTC LLC

Perth Amboy NJ 08861

www.nobleotc.com

Packaging

INGREDIENTS AND APPEARANCE

NOBLEAID

acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81533-500
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICA (UNII: V8A1AW0880)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	red	Score	no score
Shape	capsule (Caplet)	Size	19mm
Flavor		Imprint Code	500
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81533-500-30	300 in 1 BOTTLE; Type 0: Not a Combination Product	05/10/2021	03/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	05/10/2021	03/31/2023

Labeler - Noble Otc LLC (041836435)

Revised: 7/2022

Document Id: 6983b2fd-9ea0-4bca-9f47-14eadddc94cd

Set id: df5c0266-036c-435a-95f0-42d57c7fb8e3

Version: 2

Effective Time: 20220719