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.

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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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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

Other information

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
wellness™

Allergy
Multi-Symptom

Acetaminophen , Chlorpheniramine Maleate,
Phenylephrine HCl

Pain Reliever/Antihistamine/Nasal Decongestant

Relief of:
• Headache • Sinus Pressure
• Nasal Congestion
• Runny Nose • Sneezing
• Itchy, Watery Eyes

24 COOL BLAST FLAVOR
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    REV0818E45508

DISTRIBUTED BY: MIDWOOD BRANDS, LLC
10611 MONROE RD., MATTHEWS, NC 28105

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 44-455C

Family Wellness 44-455C

ALLERGY MULTI-SYMPTOM
acetaminophen, chlorpheniramine maleate and phenylephrine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-455
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 17mm
Flavor MINT Imprint Code 44;455
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55319-455-08 2 in 1 CARTON 06/28/2005
1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 06/28/2005
Labeler - Family Dollar Services Inc (024472631)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(55319-455)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(55319-455)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 PACK(55319-455)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 967626305 PACK(55319-455)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 868734088 PACK(55319-455)

Revised: 8/2019
Document Id: 1ae9e09d-e0c6-4622-bddc-bc7292c14b20
Set id: 3fd91386-3e30-4fa9-98ec-95c00f3cf869
Version: 13
Effective Time: 20190817
Family Dollar Services Inc