ALLERGY MULTI-SYMPTOM- acetaminophen, chlorpheniramine maleate and phenylephrine hcl tablet, film coated

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

Buy It Now

Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Family Dollar Services Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever Antihistamine Nasal decongestant - temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache nasal congestion runny nose and sneezing minor aches and pains sinus congestion and pressure - headache - nasal congestion - runny nose and sneezing - minor aches and pains - sinus congestion and pressure - temporarily relieves these additional symptoms of hay fever: itchy, watery eyes itching of the nose or throat - itchy, watery eyes - itching of the nose or throat - helps clear nasal passages - helps decongest sinus openings and passages
Authorization status:
OTC monograph final
Authorization number:
55319-455-08

ALLERGY MULTI-SYMPTOM- acetaminophen, chlorpheniramine maleate and phenylephrine

hcl tablet, film coated

Family Dollar Services Inc

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.

----------

Family Wellness 44-455C-AMS

Active ingredients (in each caplet)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:

headache

nasal congestion

runny nose and sneezing

minor aches and pains

sinus congestion and pressure

temporarily relieves these additional symptoms of hay fever:

itchy, watery eyes

itching of the nose or throat

helps clear nasal passages

helps decongest sinus openings and passages

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

difficulty in urination due to enlargement of the prostate gland

glaucoma

high blood pressure

a breathing problem such as emphysema or chronic bronchitis

heart disease

thyroid disease

diabetes

liver disease

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

When using this product

do not exceed recommended dosage

excitability may occur, especially in children

alcohol, sedatives, and tranquilizers may increase drowsiness

avoid alcoholic beverages

use caution when driving a motor vehicle or operating machinery

drowsiness may occur

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, 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

NDC 55319-455-08

FAMILY

wellnes s ™

Allergy

Multi-Symptom

Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl

Pain Reliever, Antihistamine, Nasal Decongestant

Headache Runny Nose

Sinus Pressure Sneezing

Nasal Congestion Itchy, Watery Eyes

24 CAPLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF TAMPERING

50844 REV0818F45508

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

NOT 100% SATISFIED?

Return package and unused product within

30 days to any Family Dollar store for a

refund (with receipt) or exchange.

Family Wellness 4 4 -4 55C

ALLERGY MULTI-SYMPTOM

acetaminophen, chlorpheniramine maleate and phenylephrine hcl tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55319 -455

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

CHLO RPHENIRAMINE MALEATE (UNII: V1Q0 O9 OJ9 Z) (CHLORPHENIRAMINE -

UNII:3U6 IO 19 6 5U)

CHLORPHENIRAMINE

MALEATE

2 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

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

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

STARCH, CO RN (UNII: O8 232NY3SJ)

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

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

TALC (UNII: 7SEV7J4R1U)

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

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

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

Family Dollar Services Inc

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

OVAL

S iz e

17mm

Flavor

MINT

Imprint Code

44;455

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:55319 -455-0 8

2 in 1 CARTON

0 6 /28 /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 6 /28 /20 0 5

Labeler -

Family Dollar Services Inc (024472631)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(55319 -455)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(55319 -455)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(55319 -455)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(55319 -455)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(55319 -455)

Revised: 12/2019

Similar products

Search alerts related to this product

View documents history

Share this information