PAIN RELIEF NON DROWSY DAYTIME- acetaminophen, phenylephrine hcl tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Better Living Brands, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Nasal decongestant - temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: minor aches and pains headache nasal congestion sinus congestion and pressure - minor aches and pains - headache - nasal congestion - sinus congestion and pressure - helps decongest sinus openings and passages - promotes sinus drainage - helps clear nasal passages - temporarily reduces fever
Authorization status:
OTC monograph final
Authorization number:
21130-466-08

PAIN RELIEF NON DROWSY DAYTIME- acetaminophen, phenylephrine hcl tablet

Better Living Brands, LLC

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.

----------

Signature Care 44-466C

Active ingredients (in each caplet)

Acetaminophen 325 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Nasal decongestant

Uses

temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and

the common cold:

minor aches and pains

headache

nasal congestion

sinus congestion and pressure

helps decongest sinus openings and passages

promotes sinus drainage

helps clear nasal passages

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:

blisters

rash

skin reddening

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 are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for

depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after

stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a

doctor or pharmacist before taking this product.

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

difficulty in urination due to enlargement of the prostate gland

heart disease

diabetes

thyroid disease

high blood pressure

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur

pain or nasal congestion gets worse or lasts more than 7 days

new symptoms occur

fever gets worse or lasts more than 3 days

redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222)

right away. Prompt 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

adults and children 12 years and over

take 2 caplets every 4 hours

swallow whole – do not crush, chew, or dissolve

do not take more than 10 caplets in 24 hours

children under 12 years: ask a doctor

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS

TORN OR BROKEN

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red

#40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol,

polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc,

titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Signature

care

Quality

Guaranteed

COMPARE TO

Tylenol

SINUS + HEADACHE

active ingredients*

NDC 21130-466-08

Non-Drowsy Daytime

Pain Relief

Sinus Congestion

ACETAMINOPHEN 325 mg

- Pain Reliever / Fever Reducer

PHENYLEPHRINE HCl 5 mg

- Nasal Decongestant

Relief of:

Headache, sinus pressure,

nasal congestion

Actual Size

24 CAPLETS

*This product is not manufactured or distributed by Johnson & Johnson Corporation, distributors of

Tylenol

SINUS + HEADACHE.

50844 REV0818B46608

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

OUR PROMISE

100% GUARANTEED

QUALITY & SATISFACTION

OR YOUR MONEY BACK.

Sig nature Care 4 4 -4 66C

PAIN RELIEF NON DROWSY DAYTIME

acetaminophen, phenylephrine hcl tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:21130 -46 6

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

D&C YELLO W NO . 10 ALUMINUM LAKE (UNII: CQ3XH3DET6 )

FD&C BLUE NO . 1 ALUMINUM LAKE (UNII: J9 EQA3S2JM)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

Better Living Brands, LLC

Product Characteristics

Color

GREEN

S core

no sco re

S hap e

OVAL

S iz e

17mm

Flavor

MINT

Imprint Code

44;46 6

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:21130 -46 6 -0 8

2 in 1 CARTON

0 7/26 /20 0 5

1

12 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 7/26 /20 0 5

Labeler -

Better Living Brands, LLC (009137209)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(21130 -46 6 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(21130 -46 6 )

Revised: 5/2020

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