GOOD NEIGHBOR PHARMACY COLD MULTI SYMPTOM- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated

good neighbor pharmacy cold by

Drug Labeling and Warnings

good neighbor pharmacy cold by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

• for the temporary relief of the following cold/flu symptoms:
• minor aches and pains
• sore throat
• cough
• headache
• nasal congestion
• impulse to cough
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily reduces fever

Warnings

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

• more than 12 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.

Ask a doctor before use if you have

• liver disease
• thyroid disease
• diabetes
• heart disease
• high blood pressure
• trouble urinating due to an enlarged prostate gland
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
• cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• pain, nasal congestion or cough gets worse or lasts more than 7 days
• new symptoms occur
• fever gets worse or lasts more than 3 days
• cough comes back or occurs with rash or headache that lasts
• 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 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 Liver warning)

• 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 12 caplets in 24 hours
• children under 12 years:
  • do not use this adult product in children under 12 years of age

Other information

• each caplet contains: sodium 3 mg

Inactive ingredients

acesulfame potassium, carnauba wax, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

See New Warnings Information

Compare To Active Ingredients In Tylenol® Cold Multi-Symptom Severe Cool Burst® Caplets

Cold

Multi-Symptom

Severe

Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant, Expectorant

Contains 4 Medicines:

Fever/Headache/Sore Throat – Acetaminophen

Nasal Congestion – Phenylephrine HCl

Coughing – Dextromethorphan HBr

Chest Congestion – Guaifenesin

Cool Ice® Instant Cooling Sensation

Daytime

Non-Drowsy

Cold Carton Image 1

Cold Carton Image 2

INGREDIENTS AND APPEARANCE

GOOD NEIGHBOR PHARMACY COLD  MULTI SYMPTOM
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24385-066
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE (UNII: 68401960MK)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL (UNII: 532B59J990)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	YELLOW	Score	no score
Shape	OVAL (capsule shaped)	Size	20mm
Flavor	VANILLA (menthol)	Imprint Code	L234
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24385-066-62	2 in 1 CARTON
1		12 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/30/1993

Labeler - Amerisource Bergen (007914906)