healthy mama

Manufacturer: MATERNAL SCIENCE, LLC
Effective date: 2013-04-18
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:35:24

Label at a glance#

Producthealthy mama SHAKE THAT ACHE

Active ingredientACETAMINOPHEN

Label structure9 sections

Indications and uses

for the temporary relief of minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

Do not take more than directed (see overdose warning) Adults and 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 take for more than 10 days unless directed by a doctor Children under 12 years: ask a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains due to:

headache
muscular aches
backache
minor pain of arthritis
the common cold
toothache
premenstrual and menstrual cramps
temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. 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

Do not use

OTC - DO NOT USE SECTION

with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
new symptoms occur
redness or swelling is present

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In the 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

DOSAGE & ADMINISTRATION SECTION

Do not take more than directed (see overdose warning)

Adults and 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 take for more than 10 days unless directed by a doctor

Children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Do not use if imprinted safety seal under cap is broken or missing.
Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?

OTC - QUESTIONS SECTION

If you have any questions or comments, or to report an adverse event, please contact (xxx) xxx-xxxx.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

healthy

mama

SHAKE THAT ACHE!

EXTRA STRENGTH PAIN RELIEVER

aspirin free

100 caplets( 500 mg each)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	1
198440	acetaminophen 500 MG Oral Tablet	SCD	1
198440	APAP 500 MG Oral Tablet	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58154-100-01	2019-11-27	C162847	48780-1	9855d018-d48a-cd31-e053-dbdaa90ab51a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58154-100-01	healthy mamaSHAKE THAT ACHE	100 in 1 BOTTLE, PLASTIC	TABLET	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58154-100	HEALTHY MAMA SHAKE THAT ACHE (ACETAMINOPHEN) TABLET [MATERNAL SCIENCE, LLC]	1	Legacy NDC, 1 package rows	20130510_87a39b40-8364-4cfa-a4bd-1a4ac7bbce95.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58154-100-01	EA - Each	58154-100	f286cb98-9f12-43ca-b923-dbb0b87617a1	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

healthy mama SHAKE THAT ACHE
ACETAMINOPHEN
POVIDONE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58154-100	58154-100-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETAMINOPHEN	362O9ITL9D	ACTIB
POVIDONE	FZ989GH94E	IACT
STARCH, CORN	O8232NY3SJ	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 78 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION/ DROPS / ORAL		90 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / BUCCAL	6 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SYSTEM / TOPICAL		41 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SHAMPOO / TOPICAL	9.7 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, COATED PELLETS / ORAL	10.03 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, CHEWABLE / ORAL		48 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SOLUTION / ORAL		3000 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FOR SUSPENSION / ORAL	2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	CREAM / TOPICAL		190 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL		336 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	DROPS / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, ORALLY DISINTEGRATING / ORAL	15.03 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TROCHE / ORAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	17 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED / ORAL		176 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, DELAYED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / SUBLINGUAL	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	POWDER, FOR SUSPENSION / ORAL	35 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	IMPLANT / SUBCUTANEOUS	6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, EXTENDED RELEASE / ORAL		56 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	LOTION / TOPICAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SOLUTION / OPHTHALMIC	1.8 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	OINTMENT / TOPICAL	15 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / VAGINAL	4 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION, EXTENDED RELEASE / ORAL		113 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	INJECTION / INTRAMUSCULAR	0.2 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION/ DROPS / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
97e6afc8-b5b0-452c-ba0c-3f64d167e216			87a39b40-8364-4cfa-a4bd-1a4ac7bbce95	2013-04-18	Warnings	Exact identifier spl id: 97e6afc8-b5b0-452c-ba0c-3f64d167e216 spl set id: 87a39b40-8364-4cfa-a4bd-1a4ac7bbce95

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.