Dr. Reckeweg R14 Quieta

Dr. Reckeweg R14 Quieta
SPL v2
SPL
SPL Set ID b4cba022-c38c-4308-9be6-8eb99e6aacbd
Route
ORAL
Published
Effective Date 2013-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bromide Ion (3 [hp_X]) Avena Sativa Flowering Top (1 [hp_X]) Matricaria Recutita (4 [hp_X]) Arabica Coffee Bean (2 [hp_X]) Eschscholzia Californica Flowering Top (6 [hp_X]) Hops Strychnos Ignatii Seed Passiflora Incarnata Flowering Top Valerian Valeric Acid
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 1986-06-01

Description

Active ingredients Ammonium bromatum 3X, Avena sativa 1X, Chamomilla 4X, Coffea cruda 4X, Eschscholtzia californica 2X, Humulus lupulus 2X, Ignatia amara 6X, Passiflora incarnata 2X, Valeriana officinalis 1X, Zincum valerianicum 6X, 1 g each in 10 g.


Medication Information

Warnings and Precautions

Warnings

Indications and Usage


Uses

For the temporary relief of:



  • Sleeplessness caused by worry, overwork, stress and tension
Dosage and Administration

Directions

Adults and children ≥ 12 years 5-10 drops 3 times daily in a little water or undiluted or as recommended.

Not recommended for children under 12 years of age except under the advice of a health care professional.

Description

Active ingredients Ammonium bromatum 3X, Avena sativa 1X, Chamomilla 4X, Coffea cruda 4X, Eschscholtzia californica 2X, Humulus lupulus 2X, Ignatia amara 6X, Passiflora incarnata 2X, Valeriana officinalis 1X, Zincum valerianicum 6X, 1 g each in 10 g.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks
  • sleeplessness may be a symptom of serious underlying medical illness.  

Section 50569-3

Ask a doctor before use in children younger than 12 years.

Section 51727-6

Inactive ingredients

Ethanol, purified water.

Section 51945-4

NDC# 53346-1314-5

Dr. Reckeweg R14 Quieta

Homeopathic preparation for the temporary relief of:

  • Sleeplessness caused by worry, overwork, stress and tension

Manufactured by:

Dr. Reckeweg Co. GmbH

D-64625 Bensheim

Germany

1.68 fl oz

(50 ml)

Section 53413-1


Questions?

Call 1-800-361-7872 or email [email protected]

Section 53414-9

If pregnant or breastfeeding, ask a health care professional before use.

Section 55105-1


Purpose

Relieves sleeplessness caused by worry, overwork, stress and tension

Section 55106-9

Active ingredients

Ammonium bromatum 3X, Avena sativa 1X, Chamomilla 4X, Coffea cruda 4X, Eschscholtzia californica 2X, Humulus lupulus 2X, Ignatia amara 6X, Passiflora incarnata 2X,

Valeriana officinalis 1X, Zincum valerianicum 6X, 1 g each in 10 g.

Section 60561-8

Other information

  • Tamper resistant: do not use if safety ring at base of cap is broken.
  • Retain outer carton for full product information.

Structured Label Content

Indications and Usage (34067-9)


Uses

For the temporary relief of:



  • Sleeplessness caused by worry, overwork, stress and tension
Dosage and Administration (34068-7)

Directions

Adults and children ≥ 12 years 5-10 drops 3 times daily in a little water or undiluted or as recommended.

Not recommended for children under 12 years of age except under the advice of a health care professional.

Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than 2 weeks
  • sleeplessness may be a symptom of serious underlying medical illness.  

Section 50569-3 (50569-3)

Ask a doctor before use in children younger than 12 years.

Section 51727-6 (51727-6)

Inactive ingredients

Ethanol, purified water.

Section 51945-4 (51945-4)

NDC# 53346-1314-5

Dr. Reckeweg R14 Quieta

Homeopathic preparation for the temporary relief of:

  • Sleeplessness caused by worry, overwork, stress and tension

Manufactured by:

Dr. Reckeweg Co. GmbH

D-64625 Bensheim

Germany

1.68 fl oz

(50 ml)

Section 53413-1 (53413-1)


Questions?

Call 1-800-361-7872 or email [email protected]

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health care professional before use.

Section 55105-1 (55105-1)


Purpose

Relieves sleeplessness caused by worry, overwork, stress and tension

Section 55106-9 (55106-9)

Active ingredients

Ammonium bromatum 3X, Avena sativa 1X, Chamomilla 4X, Coffea cruda 4X, Eschscholtzia californica 2X, Humulus lupulus 2X, Ignatia amara 6X, Passiflora incarnata 2X,

Valeriana officinalis 1X, Zincum valerianicum 6X, 1 g each in 10 g.

Section 60561-8 (60561-8)

Other information

  • Tamper resistant: do not use if safety ring at base of cap is broken.
  • Retain outer carton for full product information.

Advanced Ingredient Data


Raw Label Data

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